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OpenTrials
Completed

NCT Number: NCT05051501

The Effects of Microbiological Spectrum Changes to Improve Cognitive Health in Aging Population

The goal of this project is to develop probiotic dietary supplements intended for the elderly, which can modify the composition of the intestinal microbiota typically occurring in the aging population. According to currently held scientific knowledge, it is postulated that the probiotics-induced normalization of the physiological axis in the brain-intestinal microbiota affects the activity of the nervous system. Thus, normalization of this axis should lead to observable improvements in cognitive functions and quality of life.

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Key information

Conditions

Memory Deficits Aging Aging Problems Cognition Disorders Cognitive Decline Cognitive Dysfunction Gut Health Memory Disorders Mental Disorders Mood Change Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National Institute of Mental Health, Czech Republic, Prague, Czechia

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About this study

With an increasing age of the population, the incidence of age-related problems, such as memory deficits or negative changes in mood, is on the rise. On this account, an increased emphasis has been placed on identifying natural ways to reduce the occurrence of such problems. One of the proposed methods to achieve this is to modify the composition of gut bacteria and their by-products, which has shown a surprising, yet highly promising potential to benefit the brain function and blood composition.

In the recent years, gut bacteria have been of great interest to many medical professionals from various disciplines. It is postulated that they might exert some influence on memory and emotions, but there is a lack of evidence to confirm these hypotheses. Our study would like to address this issue and examine the beneficial effects of probiotics into more depth. Probiotics are dietary supplements in the form of bacteria, which are often artificially added e.g. into some dairy products. This is done to promote gut health and to improve the quality of gut microflora.

The subject selection and assessment are summarised as follows: Participants will be pre-selected electronically and given an electronic memory test. Further selection of eligible subjects based on their preliminary results will be followed by the first personal appointment, where each participant will undergo memory and mood-focused psychological testing and testing for gut bacteria composition. One week after the initial appointment, participants will be asked to bring in a stool and urine sample, their blood will be collected and their fitness and dietary habits assessed. Each participant will also be given an electronic watch, which will monitor their physical activity, and supplements in the pill form, which either contain specially cultivated human gut bacteria (i.e. probiotics) or placebo. Identical tests and blood, urine and stool collection will be repeated three months after administering the first pill. The participants will receive another set of pills, which will contain the probiotics if the participant has initially received placebo and vice versa. After three more months, participants will be subjected to the same tests as in the previous two instants. To test for lasting effects of treatment, participants will be tested again after 3 more months and the project will reach its termination.

Using the above-mentioned methods, the aim of this project is to provide sufficient evidence of the beneficial effects of the new probiotics on memory, mood and the biochemical components contained in the blood, stool and urine in elderly population.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • is 55-80 years of age
  • His/her native language is Czech
  • Is willing to visit the testing centre four times within half a year
  • Is willing to provide blood, urine and stool samples three times within half a year
  • Is willing to self-administer the probiotic/placebo pill once every day for half a year
  • is self-sufficient (handling finances, travelling without a chaperone, administration of medication, correct phone usage, filling forms, meal preparation)
  • Has good vision; Can read and write, glasses are acceptable
  • Has good hearing to hear and understand all instructions during examination
  • Can walk well (walking aids are acceptable) to attend all the examinations

Exclusion criteria

  • Suffers with disorder(s) of digestive system, primarily gastrointestinal disorders (celiac disease, ulcerative colitis, Crohn's disease, frequent diarrhoea)
  • Had severe neurological difficulties (epilepsy, stroke, severe head trauma, meningitis in the past 10 years, brain surgery, brain tumour, prolonged period(s) in an unconscious state - excluding general anaesthesia)
  • Had been treated/Is currently being treated for the following psychiatric disorders: alcohol/medication/drug of abuse dependance, schizophrenia, psychotic disorder, bipolar disorder
  • Is taking medication for depression or low mood
  • Suffers from internal organ failure (heart, liver or kidney failure etc.)
  • Suffered from an oncological problem (cancer) in the past 5 years
  • Underwent radiotherapy or chemotherapy in the past
  • Underwent a surgery/procedure under general anaesthesia in the past three years or has a planned procedure/surgery under general anaesthesia in the next 6 months over the course of this trial
  • Suffered from hepatitis (hepatitis B, C), HIV or syphilis in the past
  • Had taken any probiotics in the past three months

Treatment and study plan

Probiotics C2P

Dietary Supplement

Probiotics will supplement normal diet. Unlike other products available on the market, which are usually of bovine origin, our probiotic has been manufactured using human-stemmed lines. The supplements are composed of a mixture of naturally occurring human gut bacteria.

Primary outcomes

  1. Change from baseline cognitive function in the Amnesia Light and Brief Assessment (ALBA) at 3 months

    Time frame: baseline to 3 months

    ALBA is a validated measure assessing memory. The scale spans 0-12 points with higher number of points signifying better outcome

  2. Change from baseline cognitive function in the Amnesia Light and Brief Assessment (ALBA) at 6 months

    Time frame: baseline to 6 months

    ALBA is a validated measure assessing memory. The scale spans 0-12 points with higher number of points signifying better outcome

  3. Change from 3 months cognitive function in the Amnesia Light and Brief Assessment (ALBA) at 6 months

    Time frame: 3 months to 6 months

    ALBA is a validated measure assessing memory. The scale spans 0-12 points with higher number of points signifying better outcome

  4. Change from 6 months cognitive function in the Amnesia Light and Brief Assessment (ALBA) at 9 months

    Time frame: 6 months to 9 months

    ALBA is a validated measure assessing memory. The scale spans 0-12 points with higher number of points signifying better outcome

  5. Difference in cognitive function in the Amnesia Light and Brief Assessment (ALBA) at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Time frame: 3 months

    ALBA is a validated measure assessing memory. The scale spans 0-12 points with higher number of points signifying better outcome

  6. Difference in cognitive function in the Amnesia Light and Brief Assessment (ALBA) at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Time frame: 6 months

    ALBA is a validated measure assessing memory. The scale spans 0-12 points with higher number of points signifying better outcome

  7. Change from baseline cognitive function in the Assessment Battery of Cognition (ABACO) at 3 months

    Time frame: baseline to 3 months

    ABACO is a measure of cognitive function, results are in points and range from 0-35, higher point attainment signals better outcome

  8. Change from baseline cognitive function in the Assessment Battery of Cognition (ABACO) at 6 months

    Time frame: baseline to 6 months

    ABACO is a measure of cognitive function, results are in points and range from 0-35, higher point attainment signals better outcome

  9. Change from 3 months cognitive function in the Assessment Battery of Cognition (ABACO) at 6 months

    Time frame: 3 months to 6 months

    ABACO is a measure of cognitive function, results are in points and range from 0-35, higher point attainment signals better outcome

  10. Change from 6 months cognitive function in the Assessment Battery of Cognition (ABACO) at 9 months

    Time frame: 6 months to 9 months

    ABACO is a measure of cognitive function, results are in points and range from 0-35, higher point attainment signals better outcome

  11. Difference in cognitive function in the Assessment Battery of Cognition (ABACO) at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Time frame: 3 months

    ABACO is a measure of cognitive function, results are in points and range from 0-35, higher point attainment signals better outcome

  12. Difference in cognitive function in the Assessment Battery of Cognition (ABACO) at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Time frame: 6 months

    ABACO is a measure of cognitive function, results are in points and range from 0-35, higher point attainment signals better outcome

  13. Change from baseline cognitive function in Semantic word recollection (category: animals, 1 min) at 3 months

    Time frame: baseline to 3 months

    Semantic word recollection is a measure of cognitive function, results range from 0-cca 40, more points signify better outcome

  14. Change from baseline cognitive function in Semantic word recollection (category: animals, 1 min) at 6 months

    Time frame: baseline to 6 months

    Semantic word recollection is a measure of cognitive function, results range from 0-cca 40, more points signify better outcome

  15. Change from 3 months cognitive function in Semantic word recollection (category: animals, 1 min) at 6 months

    Time frame: 3 months to 6 months

    Semantic word recollection is a measure of cognitive function, results range from 0-cca 40, more points signify better outcome

  16. Change from 6 months cognitive function in Semantic word recollection (category: animals, 1 min) at 9 months

    Time frame: 6 months to 9 months

    Semantic word recollection is a measure of cognitive function, results range from 0-cca 40, more points signify better outcome

  17. Difference in cognitive function in Semantic word recollection (category: animals, 1 min) at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Time frame: 3 months

    Semantic word recollection is a measure of cognitive function, results range from 0-cca 40, more points signify better outcome

  18. Difference in cognitive function in Semantic word recollection (category: animals, 1 min) at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Time frame: 6 months

    Semantic word recollection is a measure of cognitive function, results range from 0-cca 40, more points signify better outcome

  19. Change from baseline cognitive function in Rey Auditory Verbal Learning Test (RAVLT) at 3 months

    Time frame: baseline to 3 months

    RAVLT is a validated measure of cognitive function, it has 8 subscales, each of them ranging from 0-15, measured in raw scores which are connected to age-dependent population norm

  20. Change from baseline cognitive function in Rey Auditory Verbal Learning Test (RAVLT) at 6 months

    Time frame: baseline to 6 months

    RAVLT is a validated measure of cognitive function, it has 8 subscales, each of them ranging from 0-15, measured in raw scores which are connected to age-dependent population norm

  21. Change from 3 months cognitive function in Rey Auditory Verbal Learning Test (RAVLT) at 6 months

    Time frame: 3 months to 6 months

    RAVLT is a validated measure of cognitive function, it has 8 subscales, each of them ranging from 0-15, measured in raw scores which are connected to age-dependent population norm

  22. Change from 6 months cognitive function in Rey Auditory Verbal Learning Test (RAVLT) at 9 months

    Time frame: 6 months to 9 months

    RAVLT is a validated measure of cognitive function, it has 8 subscales, each of them ranging from 0-15, measured in raw scores which are connected to age-dependent population norm

  23. Difference in cognitive function in Rey Auditory Verbal Learning Test (RAVLT) at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Time frame: 3 months

    RAVLT is a validated measure of cognitive function, it has 8 subscales, each of them ranging from 0-15, measured in raw scores which are connected to age-dependent population norm

  24. Difference in cognitive function in Rey Auditory Verbal Learning Test (RAVLT) at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Time frame: 6 months

    RAVLT is a validated measure of cognitive function, it has 8 subscales, each of them ranging from 0-15, measured in raw scores which are connected to age-dependent population norm

  25. Change in baseline cognitive function in Wechsler Adult Intelligence Scale, Third edition (WAIS III) - "Symbols" subtest at 3 months

    Time frame: baseline to 3 months

    The WAIS III, subtest "Symbols" is a validated measure of cognitive function, the point scale ranges from 0-133 with larger point attainment signalling better outcome

  26. Change in baseline cognitive function in Wechsler Adult Intelligence Scale, Third edition (WAIS III) - "Symbols" subtest at 6 months

    Time frame: baseline to 6 months

    The WAIS III, subtest "Symbols" is a validated measure of cognitive function, the point scale ranges from 0-133 with larger point attainment signalling better outcome

  27. Change in 3 month cognitive function in Wechsler Adult Intelligence Scale, Third edition (WAIS III) - "Symbols" subtest at 6 months

    Time frame: 3 months to 6 months

    The WAIS III, subtest "Symbols" is a validated measure of cognitive function, the point scale ranges from 0-133 with larger point attainment signalling better outcome

  28. Change in 6 month cognitive function in Wechsler Adult Intelligence Scale, Third edition (WAIS III) - "Symbols" subtest at 9 months

    Time frame: 6 months to 9 months

    The WAIS III, subtest "Symbols" is a validated measure of cognitive function, the point scale ranges from 0-133 with larger point attainment signalling better outcome

  29. Difference in cognitive function in Wechsler Adult Intelligence Scale, Third edition (WAIS III) - "Symbols" subtest at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Time frame: 3 months

    The WAIS III, subtest "Symbols" is a validated measure of cognitive function, the point scale ranges from 0-133 with larger point attainment signalling better outcome

  30. Difference in cognitive function in Wechsler Adult Intelligence Scale, Third edition (WAIS III) - "Symbols" subtest at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Time frame: 6 months

    The WAIS III, subtest "Symbols" is a validated measure of cognitive function, the point scale ranges from 0-133 with larger point attainment signalling better outcome

  31. Change in baseline cognitive function in Trail Making Test (TMT), Parts A & B at 3 months

    Time frame: baseline to 3 months

    The TMT is a validated measure of cognitive function, the time upon completion is measured

  32. Change in baseline cognitive function in Trail Making Test (TMT), Parts A & B at 6 months

    Time frame: baseline to 6 months

    The TMT is a validated measure of cognitive function, the time upon completion is measured

  33. Change in 3 month cognitive function in Trail Making Test (TMT), Parts A & B at 6 months

    Time frame: 3 months to 6 months

    The TMT is a validated measure of cognitive function, the time upon completion is measured

  34. Change in 6 month cognitive function in Trail Making Test (TMT), Parts A & B at 9 months

    Time frame: 6 months to 9 months

    The TMT is a validated measure of cognitive function, the time upon completion is measured

  35. Difference cognitive function in Trail Making Test (TMT), Parts A & B at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Time frame: 3 months

    The TMT is a validated measure of cognitive function, the time upon completion is measured

  36. Difference cognitive function in Trail Making Test (TMT), Parts A & B at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Time frame: 6 months

    The TMT is a validated measure of cognitive function, the time upon completion is measured

  37. Change in baseline mood in Geriatric Depression Scale at 3 months.

    Time frame: baseline to 3 months

    A self-report measure of mood, measured on 0-15 point scale, higher point attainment signifies worse outcome

  38. Change in baseline mood in Geriatric Depression Scale at 6 months.

    Time frame: baseline to 6 months

    A self-report measure of mood, measured on 0-15 point scale, higher point attainment signifies worse outcome

  39. Change in 3 month mood in Geriatric Depression Scale at 6 months.

    Time frame: 3 months to 6 months

    A self-report measure of mood, measured on 0-15 point scale, higher point attainment signifies worse outcome

  40. Change in 6 month mood in Geriatric Depression Scale at 9 months.

    Time frame: 6 months to 9 months

    A self-report measure of mood, measured on 0-15 point scale, higher point attainment signifies worse outcome

  41. Difference in mood in Geriatric Depression Scale at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Time frame: 3 months

    A self-report measure of mood, measured on 0-15 point scale, higher point attainment signifies worse outcome

  42. Difference in mood in Geriatric Depression Scale at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Time frame: 6 months

    A self-report measure of mood, measured on 0-15 point scale, higher point attainment signifies worse outcome

  43. Change from baseline self-sufficiency self-reported in Questionnaire of functional state (abbreviation in original language: subjective FAQ-CZ) at 3 months

    Time frame: baseline to 3 months

    FAQ-CZ is a self-report measure of self-sufficiency, it is measured on a scale of 0-30 with higher point attainment signalling worse outcome

  44. Change from baseline self-sufficiency self-reported in Questionnaire of functional state (abbreviation in original language: subjective FAQ-CZ) at 6 months

    Time frame: baseline to 6 months

    FAQ-CZ is a self-report measure of self-sufficiency, it is measured on a scale of 0-30 with higher point attainment signalling worse outcome

  45. Change from 3 month self-sufficiency self-reported in Questionnaire of functional state (abbreviation in original language: subjective FAQ-CZ) at 6 months

    Time frame: 3 months to 6 months

    FAQ-CZ is a self-report measure of self-sufficiency, it is measured on a scale of 0-30 with higher point attainment signalling worse outcome

  46. Change from 6 month self-sufficiency self-reported in Questionnaire of functional state (abbreviation in original language: subjective FAQ-CZ) at 9 months

    Time frame: 6 months to 9 months

    FAQ-CZ is a self-report measure of self-sufficiency, it is measured on a scale of 0-30 with higher point attainment signalling worse outcome

  47. Difference in self-sufficiency self-reported in Questionnaire of functional state (abbreviation in original language: subjective FAQ-CZ) at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Time frame: 3 months

    FAQ-CZ is a self-report measure of self-sufficiency, it is measured on a scale of 0-30 with higher point attainment signalling worse outcome

  48. Difference in self-sufficiency self-reported in Questionnaire of functional state (abbreviation in original language: subjective FAQ-CZ) at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Time frame: 6 months

    FAQ-CZ is a self-report measure of self-sufficiency, it is measured on a scale of 0-30 with higher point attainment signalling worse outcome

  49. Changes in tau protein

    Time frame: baseline to 3 months

    Measured in pg/ml; 2x10ml samples collected to assess tau protein, neurofilament light and immunocomplex antibody levels

  50. Changes in tau protein

    Time frame: baseline to 6 months

    Measured in pg/ml; 2x10ml samples collected to assess tau protein, neurofilament light and immunocomplex antibody levels

  51. Changes in tau protein

    Time frame: 3 months to 6 months

    Measured in pg/ml; 2x10ml samples collected to assess tau protein, neurofilament light and immunocomplex antibody levels

  52. Changes in tau protein

    Time frame: 6 months to 9 months

    Measured in pg/ml; 2x10ml samples collected to assess tau protein, neurofilament light and immunocomplex antibody levels

  53. Changes in neurofilament light levels

    Time frame: baseline to 3 months

    Measured in pg/ml; 2x10ml samples collected to assess tau protein, neurofilament light and immunocomplex antibody levels

  54. Changes in neurofilament light levels

    Time frame: baseline to 6 months

    Measured in pg/ml; 2x10ml samples collected to assess tau protein, neurofilament light and immunocomplex antibody levels

  55. Changes in neurofilament light levels

    Time frame: 3 months to 6 months

    Measured in pg/ml; 2x10ml samples collected to assess tau protein, neurofilament light and immunocomplex antibody levels

  56. Changes in neurofilament light levels

    Time frame: 6 months to 9 months

    Measured in pg/ml; 2x10ml samples collected to assess tau protein, neurofilament light and immunocomplex antibody levels

  57. Changes in immunocomplex antibody levels

    Time frame: baseline to 3 months

    Measured in ng/ml; 2x10ml samples collected to assess tau protein, neurofilament light and immunocomplex antibody levels

  58. Changes in immunocomplex antibody levels

    Time frame: baseline to 6 months

    Measured in ng/ml; 2x10ml samples collected to assess tau protein, neurofilament light and immunocomplex antibody levels

  59. Changes in immunocomplex antibody levels

    Time frame: 3 months to 6 months

    Measured in ng/ml; 2x10ml samples collected to assess tau protein, neurofilament light and immunocomplex antibody levels

  60. Changes in immunocomplex antibody levels

    Time frame: 6 months to 9 months

    Measured in ng/ml; 2x10ml samples collected to assess tau protein, neurofilament light and immunocomplex antibody levels

  61. Biochemical parameters in blood

    Time frame: baseline to 3 months

    Change from baseline Blood metabolome assessed using mass spectrometry at 3 months

  62. Biochemical parameters in blood

    Time frame: baseline to 6 months

    Change from baseline Blood metabolome assessed using mass spectrometry at 6 months

  63. Biochemical parameters in blood

    Time frame: 3 months to 6 months

    Change from 3 months Blood metabolome assessed using mass spectrometry at 6 months

  64. Biochemical parameters in blood

    Time frame: 6 months to 9 months

    Change from 3 months Blood metabolome assessed using mass spectrometry at 6 months

  65. Biochemical parameters in urine

    Time frame: baseline to 3 months

    15ml sample collected twice at each visitation time point (at home in the morning, during centre visit); Change from baseline Urine metabolome assessed using mass spectrometry at 3 months

  66. Biochemical parameters in urine

    Time frame: baseline to 6 months

    15ml sample collected twice at each visitation time point (at home in the morning, during centre visit); Change from baseline Urine metabolome assessed using mass spectrometry at 6 months

  67. Biochemical parameters in urine

    Time frame: 3 months to 6 months

    15ml sample collected twice at each visitation time point (at home in the morning, during centre visit); Change from 3 months Urine metabolome assessed using mass spectrometry at 6 months

  68. Biochemical parameters in urine

    Time frame: 6 months to 9 months

    15ml sample collected twice at each visitation time point (at home in the morning, during centre visit); Change from 3 months Urine metabolome assessed using mass spectrometry at 6 months

  69. Biochemical parameters in stool

    Time frame: baseline to 3 months

    Change from baseline Stool metabolome assessed using mass spectrometry at 3 months

  70. Biochemical parameters in stool

    Time frame: baseline to 6 months

    Change from baseline Stool metabolome assessed using mass spectrometry at 6 months

  71. Biochemical parameters in stool

    Time frame: 3 months to 6 months

    Change from 3 months Stool metabolome assessed using mass spectrometry at 6 months

  72. Biochemical parameters in stool

    Time frame: 6 months to 9 months

    Change from 3 months Stool metabolome assessed using mass spectrometry at 6 months

Secondary outcomes

  1. Change from baseline Questionnaire of adverse events (abbreviation in original language: DNU) at 3 months

    Time frame: baseline to 3 months

    DNU is a self-report measure of adverse events, scale ranges from 0-22 points with higher point outcome indicating more adverse events

  2. Change from baseline Questionnaire of adverse events (abbreviation in original language: DNU) at 6 months

    Time frame: baseline to 6 months

    DNU is a self-report measure of adverse events, scale ranges from 0-22 points with higher point outcome indicating more adverse events

  3. Change from 3 months Questionnaire of adverse events (abbreviation in original language: DNU) at 6 months

    Time frame: 3 months to 6 months

    DNU is a self-report measure of adverse events, scale ranges from 0-22 points with higher point outcome indicating more adverse events

  4. Change from 6 months Questionnaire of adverse events (abbreviation in original language: DNU) at 9 months

    Time frame: 6 months to 9 months

    DNU is a self-report measure of adverse events, scale ranges from 0-22 points with higher point outcome indicating more adverse events

  5. Difference in the Questionnaire of adverse events (abbreviation in original language: DNU) at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Time frame: 3 months

    DNU is a self-report measure of adverse events, scale ranges from 0-22 points with higher point outcome indicating more adverse events

  6. Difference in the Questionnaire of adverse events (abbreviation in original language: DNU) at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Time frame: 6 months

    DNU is a self-report measure of adverse events, scale ranges from 0-22 points with higher point outcome indicating more adverse events

  7. Change from baseline Self-assessment of memory at 3 months

    Time frame: baseline to 3 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

  8. Change from baseline Self-assessment of memory at 6 months

    Time frame: baseline to 6 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

  9. Change from 3 months Self-assessment of memory at 6 months

    Time frame: 3 months to 6 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

  10. Change from 6 months Self-assessment of memory at 9 months

    Time frame: 6 months to 9 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

  11. Difference in Self-assessment of memory at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Time frame: 3 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

  12. Difference in Self-assessment of memory at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Time frame: 6 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

  13. Change from baseline Self-assessment of digestion at 3 months

    Time frame: baseline to 3 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

  14. Change from baseline Self-assessment of digestion at 6 months

    Time frame: baseline to 6 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

  15. Change from 3 months Self-assessment of digestion at 6 months

    Time frame: 3 months to 6 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

  16. Change from 6 months Self-assessment of digestion at 9 months

    Time frame: 6 months to 9 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

  17. Difference in Self-assessment of digestion at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Time frame: 3 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

  18. Difference in Self-assessment of digestion at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Time frame: 6 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

  19. Change from baseline Self-assessment of overall health at 3 months

    Time frame: baseline to 3 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

  20. Change from baseline Self-assessment of overall health at 6 months

    Time frame: baseline to 6 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

  21. Change from 3 months Self-assessment of overall health at 6 months

    Time frame: 3 months to 6 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

  22. Change from 6 months Self-assessment of overall health at 9 months

    Time frame: 6 months to 9 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

  23. Difference in Self-assessment of overall health at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Time frame: 3 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

  24. Difference in Self-assessment of overall health at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Time frame: 6 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

  25. Change from baseline Self-assessment of sleep quality at 3 months

    Time frame: baseline to 3 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

  26. Change from baseline Self-assessment of sleep quality at 6 months

    Time frame: baseline to 6 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

  27. Change from 3 months Self-assessment of sleep quality at 6 months

    Time frame: 3 months to 6 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

  28. Change from 6 months Self-assessment of sleep quality at 9 months

    Time frame: 6 months to 9 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

  29. Difference in Self-assessment of sleep quality at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Time frame: 3 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

  30. Difference in Self-assessment of sleep quality at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Time frame: 6 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

  31. Change from baseline Self-assessment of anxiety at 3 months

    Time frame: baseline to 3 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome

  32. Change from baseline Self-assessment of anxiety at 6 months

    Time frame: baseline to 6 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome

  33. Change from 3 months Self-assessment of anxiety at 6 months

    Time frame: 3 months to 6 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome

  34. Change from 6 months Self-assessment of anxiety at 9 months

    Time frame: 6 months to 9 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome

  35. Difference in Self-assessment of anxiety at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Time frame: 3 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome

  36. Difference in Self-assessment of anxiety at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Time frame: 6 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome

  37. Change from baseline Self-assessment of fatigue at 3 months

    Time frame: baseline to 3 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome

  38. Change from baseline Self-assessment of fatigue at 6 months

    Time frame: baseline to 6 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome

  39. Change from 3 months Self-assessment of fatigue at 6 months

    Time frame: 3 months to 6 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome

  40. Change from 6 months Self-assessment of fatigue at 9 months

    Time frame: 6 months to 9 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome

  41. Difference in Self-assessment of fatigue at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Time frame: 3 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome

  42. Difference in Self-assessment of fatigue at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Time frame: 6 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling worse outcome

  43. Change from baseline Self-assessment of pain at 3 months

    Time frame: baseline to 3 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

  44. Change from baseline Self-assessment of pain at 6 months

    Time frame: baseline to 6 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

  45. Change from 3 months Self-assessment of pain at 6 months

    Time frame: 3 months to 6 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

  46. Change from 6 months Self-assessment of pain at 9 months

    Time frame: 6 months to 9 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

  47. Difference in Self-assessment of pain at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Time frame: 3 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

  48. Difference in Self-assessment of pain at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Time frame: 6 months

    Self-reported on a visual scale ranging from 1-10 with higher point attainment signalling better outcome

  49. Change from baseline physical condition assessment in 30 second sit stand test at 3 months

    Time frame: baseline to 3 months

    Number of sits and stands during 30 seconds

  50. Change from baseline physical condition assessment in 30 second sit stand test at 6 months

    Time frame: baseline to 6 months

    Number of sits and stands during 30 seconds

  51. Change from 3 months physical condition assessment in 30 second sit stand test at 6 months

    Time frame: 3 months to 6 months

    Number of sits and stands during 30 seconds

  52. Change from 6 months physical condition assessment in 30 second sit stand test at 9 months

    Time frame: 6 months to 9 months

    Number of sits and stands during 30 seconds

  53. Difference in physical condition assessment in 30 second sit stand test at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Time frame: 3 months

    Number of sits and stands during 30 seconds

  54. Difference in physical condition assessment in 30 second sit stand test at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Time frame: 6 months

    Number of sits and stands during 30 seconds

  55. Change from baseline physical condition assessment in 30 second dumbell lift tests at 3 months

    Time frame: baseline to 3 months

    Number lifts during 30 seconds

  56. Change from baseline physical condition assessment in 30 second dumbell lift tests at 6 months

    Time frame: baseline to 6 months

    Number lifts during 30 seconds

  57. Change from 3 months physical condition assessment in 30 second dumbell lift tests at 6 months

    Time frame: 3 months to 6 months

    Number lifts during 30 seconds

  58. Change from 6 months physical condition assessment in 30 second dumbell lift tests at 9 months

    Time frame: 6 months to 9 months

    Number lifts during 30 seconds

  59. Difference in physical condition assessment in 30 second dumbell lift tests at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Time frame: 3 months

    Number lifts during 30 seconds

  60. Difference in physical condition assessment in 30 second dumbell lift tests at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Time frame: 6 months

    Number lifts during 30 seconds

  61. Change from baseline physical condition assessment in 30 meters walk at 3 months

    Time frame: baseline to 3 months

    Time untill completion

  62. Change from baseline physical condition assessment in 30 meters walk at 6 months

    Time frame: baseline to 6 months

    Time untill completion

  63. Change from 3 months physical condition assessment in 30 meters walk at 6 months

    Time frame: 3 months to 6 months

    Time untill completion

  64. Change from 6 months physical condition assessment in 30 meters walk at 9 months

    Time frame: 6 months to 9 months

    Time untill completion

  65. Difference in physical condition assessment in 30 meters walk at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Time frame: 3 months

    Time untill completion

  66. Difference in physical condition assessment in 30 meters walk at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Time frame: 6 months

    Time untill completion

  67. Change from baseline Structured nutritional questionnaire about long-term eating habits (abbreviation in original language: STRADO) at 3 months

    Time frame: baseline to 3 months

    Structured self-report questionnaire

  68. Change from baseline Structured nutritional questionnaire about long-term eating habits (abbreviation in original language: STRADO) at 6 months

    Time frame: baseline to 6 months

    Structured self-report questionnaire

  69. Change from 3 months Structured nutritional questionnaire about long-term eating habits (abbreviation in original language: STRADO) at 6 months

    Time frame: 3 months to 6 months

    Structured self-report questionnaire

  70. Change from 6 months Structured nutritional questionnaire about long-term eating habits (abbreviation in original language: STRADO) at 9 months

    Time frame: 6 months to 9 months

    Structured self-report questionnaire

  71. Difference in Structured nutritional questionnaire about long-term eating habits (abbreviation in original language: STRADO) at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Time frame: 3 months

    Structured self-report questionnaire

  72. Difference in Structured nutritional questionnaire about long-term eating habits (abbreviation in original language: STRADO) at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Time frame: 6 months

    Structured self-report questionnaire

  73. Change in baseline Beck's Anxienty Inventory at 3 months

    Time frame: baseline to 3 months

    Beck's Anxenty Inventory is a validated self-report measure of anxiety. The scale ranges from 0-63 points, higher point attainment signals worse outcome

  74. Change in baseline Beck's Anxienty Inventory at 6 months

    Time frame: baseline to 6 months

    Beck's Anxenty Inventory is a validated self-report measure of anxiety. The scale ranges from 0-63 points, higher point attainment signals worse outcome

  75. Change in 3 months Beck's Anxienty Inventory at 6 months

    Time frame: 3 months to 6 months

    Beck's Anxenty Inventory is a validated self-report measure of anxiety. The scale ranges from 0-63 points, higher point attainment signals worse outcome

  76. Change in 6 months Beck's Anxienty Inventory at 9 months

    Time frame: 6 months to 9 months

    Beck's Anxenty Inventory is a validated self-report measure of anxiety. The scale ranges from 0-63 points, higher point attainment signals worse outcome

  77. Difference in Beck's Anxienty Inventory at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Time frame: 3 months

    Beck's Anxenty Inventory is a validated self-report measure of anxiety. The scale ranges from 0-63 points, higher point attainment signals worse outcome

  78. Difference in Beck's Anxienty Inventory (BAI) at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Time frame: 6 months

    Beck's Anxenty Inventory is a validated self-report measure of anxiety. The scale ranges from 0-63 points, higher point attainment signals worse outcome

  79. Change in baseline Beck's Depression Inventory - II (BDI-II) at 3 months

    Time frame: baseline to 3 months

    BDI-II is a validated self-report measure of depression with scale ranging from 0-63 points, higher point attainment signals worse outcome

  80. Change in baseline Beck's Depression Inventory - II (BDI-II) at 6 months

    Time frame: baseline to 6 months

    BDI-II is a validated self-report measure of depression with scale ranging from 0-63 points, higher point attainment signals worse outcome

  81. Change in 3 months Beck's Depression Inventory - II (BDI-II) at 6 months

    Time frame: 3 months to 6 months

    BDI-II is a validated self-report measure of depression with scale ranging from 0-63 points, higher point attainment signals worse outcome

  82. Change in 6 months Beck's Depression Inventory - II (BDI-II) at 9 months

    Time frame: 6 months to 9 months

    BDI-II is a validated self-report measure of depression with scale ranging from 0-63 points, higher point attainment signals worse outcome

  83. Difference in Beck's Depression Inventory - II (BDI-II) at 3 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Time frame: 3 months

    BDI-II is a validated self-report measure of depression with scale ranging from 0-63 points, higher point attainment signals worse outcome

  84. Difference in Beck's Depression Inventory - II (BDI-II) at 6 months between the Probiotics C2P/Placebo and Placebo/C2P Probiotics group

    Time frame: 6 months

    BDI-II is a validated self-report measure of depression with scale ranging from 0-63 points, higher point attainment signals worse outcome

Sponsors and collaborators

Lead sponsor

National Institute of Mental Health, Czech Republic

Other

Collaborators

  • C2P s.r.o.
  • Ministry of Industry and Trade, Czech Republic
  • University Hospital Vinohrady

Registry information

Official study title

Biotechnology Research Into Microbiological Spectrum Changes to Improve Cognitive Functions, Depression and Other Neuropsychiatric Disorders in Aging Population

Acronym: CleverAgeBiota

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 21, 2021
Registry last updated
Jun 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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