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Completed

NCT Number: NCT04772664

Probiotics and the Gut Brain Axis- Do Probiotics Interact With the Vagal Nerve?

The purpose of this study is to investigate the effects of a multispecies probiotic on the function of the vagal nerve in patients with major depression and healthy participants in a single-center, randomized, placebo-controlled trial.

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Key information

Conditions

Depressive Disorder, Major Behavior Behavioral Symptoms Depression Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Graz

Graz, Styria, 8036, Austria

About this study

After being informed about the study and potential risks, all participants giving written informed consent will be screened for eligibility for study entry and will be randomized in a double-blind manner to receive either a multistrain probiotic or a placebo for 3 months. At entry, 1 week after inclusion, 4 weeks after inclusion and 3 months (end of study) vagal activity will be measured using a 24hr electrocardiogram.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • informed consenct
  • confirmed diagnosis of depression according to ICD-10 or DSM-V
  • age between 18 and 65 years

Exclusion criteria

  • Suicidality
  • no informed consent or no ability to provide consent
  • cardiovascular disease
  • pregnancy, breastfeeding
  • alcohol or drug dependency
  • other severe psychiatric or organic conditions (epilepsy, brain tumor, recent surgery)
  • malignant diseases
  • dementia (MMST<20)
  • severe autoimmune-disorder or immunosuppression (systemic lupus, HIV, multiple sclerosis)
  • antibiotic therapy in the last month
  • misuse of laxative
  • acute infections
  • diarrhoea
  • gastrointestinal surgeries (except appendectomy)
  • no probiotic intake in the last 6 months
  • no regular intake of other supplements, probiotics or antibiotics during the study

Treatment and study plan

Multispecies-Probiotic

Dietary Supplement

Participants in intervention group receive 2x3g of a multistrain probiotic containing Bifidobacterium bifidum W23, Bifidobacterium lactis W51, Bifidobacterium lactis W52, Lactobacillus acidophilus W22, Lactobacillus casei W56, Lactobacillus paracasei W20, Lactobacillus plantarum W62, Lactobacillus salivarius W24, Lactococcus lactis W19.

Other names: Omnibiotic-SR

Placebo supplement

Dietary Supplement

Participants in the placebo group receive 2x3 gram of a placebo supplement not containing probiotic strains.

Other names: Placebo

Primary outcomes

  1. Change of Vagal function

    Time frame: 4 measurements with 24-hr heart rate variability at study entry, one week after, 1 month after and after 3 months

    Heart rate variability parameters (logRSA; SDNN)

Secondary outcomes

  1. Change of C-reactive protein (CRP)

    Time frame: 4 time points at study entry, one week after, 1 month after and 3 months (completion of the study)

    CRP is measured from serum samples with a Cobas analyzer.

  2. Change of Interleukine-6 (IL-6)

    Time frame: 4 time points at study entry, one week after, 1 month after and 3 months (completion of the study)

    IL-6 is measured from serum samples with a Cobas analyzer.

  3. Change of Oxytocin

    Time frame: 4 time points at study entry, one week after, 1 month after and 3 months (completion of the study)

    Oxytocin will be measured from serum samples using ELISA

  4. Change of Gut microbiome analysis

    Time frame: 4 time points at study entry, one week after, 1 month after and 3 months (completion of the study)

    16S sequencing of gut microbiome samples, gut microbiota composition will be investigated with QIIME2 and characterized in terms of diversity (alpha-diversity, beta diversity) and differential bacterial abundance between time points.

  5. Change of Body mass index

    Time frame: 4 time points at study entry, one week after, 1 month after and 3 months (completion of the study)

    Weight will be measured with a calibrated scale, height will be measured with a non expandable tape. BMI will be calculated using the formula [kg/m2].

  6. Mini-international neuropsychiatric interview (M.I.N.I.)

    Time frame: at study entry

    short structured clinical interview which enables researchers to make diagnoses of psychiatric disorders according to DSM-IV or ICD-10

  7. Change in Hamilton Scale for Depression (HAMD)

    Time frame: 4 time points at study entry, one week after, 1 month after and 3 months (completion of the study)

    Scoring is based on the 17-item scale and scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression

  8. Beck Depression Inventory (BDI)

    Time frame: Change in 4 time points at study entry, one week after, 1 month after and 3 months (completion of the study)

    21-question multiple-choice self-report inventory, one of the most widely used psychometric tests for measuring the severity of depression. The rating is as follows: 0-13: minimal depression 14-19: mild depression 20-28: moderate depression 29-63: severe depression

  9. Change in Pittsburgh Sleep Quality Inventory (PSQI)

    Time frame: at study entry, after 7 days, after 4 weeks and after 3 months

    The PSQI is used to rate sleep quality. It includes a scoring key for calculating a patient's seven subscores, each of which can range from 0 to 3. The subscores are tallied, yielding a "global" score that can range from 0 to 21. A global score of 5 or more indicates poor sleep quality; the higher the score, the worse the quality.

  10. Change in Adult Attachment Scale

    Time frame: at study entry, after 7 days, after 4 weeks and after 3 months

    The scale consists of 18 items scored on a 5 point likert-type scale. It measures adult attachment styles named "Secure", "Anxious" and "Avoidant", defined as:

    • Secure = high scores on Close and Depend subscales, low score on Anxiety subscale
    • Anxious = high score on Anxiety subscale, moderate scores on Close and Depend subscales
    • Avoidant = low scores on Close, Depend, and Anxiety subscales

  11. Change in "Wiener Ernährungsprotokoll"

    Time frame: at study entry, after 7 days, after 4 weeks and after 3 months

    24-hr food recall

  12. Change in International Physical Activity Questionnaire

    Time frame: at study entry, after 7 days, after 4 weeks and after 3 months

    The IPAQ is a 27-item self-reported measure of physical activity for use with individual adult patients. There are no validated cut-offs.

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Collaborators

  • Allergosan

Registry information

Official study title

Pilot-study: Probiotics and the Gut Brain Axis- Do Probiotics Interact With the Vagal Nerve? ProBIO-HRV-study

Acronym: ProBIO-HRV

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 26, 2021
Registry last updated
Mar 15, 2024

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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