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Completed

NCT Number: NCT05738746

The Efficacy of Pasteurised Akkermansia Muciniphila in Healthy Medical Workers

Gut microbiota alterations secondary to chronic stress might serve as a triggering factor towards manifestation of somatic and mental symptoms. The administration of pasteurised A. muciniphila MucT has the capability of supporting microbiota and improving the gut barrier integrity, which might lead to decrease of inflammation and the negative health consequences of stress in healthy participants.

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Key information

Conditions

Stress Dietary Supplement Healthy

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center fo Medical Simulation, Szczecin, West Pomeranian Voivodeship, Poland

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About this study

The Gut-brain-microbiota axis (GBMA) is a bi-directional pathway, both neuronal and biochemical, between the intestine and the Central Nervous System (CNS). The gut microbiota plays a central role in gut-brain communication. The composition of intestinal microbiota and its functions play an important role in the pathogenesis of disorders of gut-brain interaction - both within the digestive tract and in the brain.

Modulation of gut microbiota with the aid of probiotics, antibiotics, or germ-free feeding protocols significantly altered stressful event-induced behavioral outcomes in rodents. Moreover, the intake of various probiotics significantly improved stress-induced anxiety and depressive-like behaviors in mice. In humans, probiotics were also documented to display some beneficial effects on mental health, including alteration of emotional bias in healthy individuals, and alleviating stress and anxiety among stressed adults.

Psychobiotics are imposed with certain limitations related to their standardization and end-shelf-life product stability. Therefore, the use of postbiotics, which contain bacterial metabolites or other bacteria derived fragments are viewed as novel solutions and alternatives to use of standard probiotics. One of novel postbiotics of interest among scientists and clinicians is pasteurized Akkermansia muciniphila MucT (PAM).

Animal studies indicate that administration of Akkermansia muciniphila can ameliorate metabolic syndrome, obesity, diabetes, and inflammatory bowel disease in animals and has psychobiotic potential. Similar to live A. muciniphila, PAM could ameliorate several diseases as well. The mechanism of action of PAM - improving gut barrier integrity - suggests the potential use to reduce the negative effects of stress. Human studies shown that PAM is safety, what was confirmed in the Scientific Opinion of EFSA. Recently A. muciniphila was approved as the Novel Food.

A proof of concept study will be conducted to verify the hypothesis that PAM reduces the psychological and somatic effects of stress.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Working in a high stress hospital department, like: emergency, trauma, intensive care, surgery, internal diseases;
  • Written informed consent to participate in this study before any study-mandated procedure;
  • Body mass index (BMI) ≥18.5 kg/m2 and ≤ 35 kg/m2;
  • A willingness and motivation to follow the study protocol.

Exclusion criteria

  • Diagnosis of autoimmune, neurological, immunocompromised, thyroid, inflammatory bowel diseases, irritable bowel syndrome, diabetes, cancer, and/or IgE-dependent allergy;
  • Psychiatric comorbidities, including mental retardation, organic brain dysfunction, or addiction (except nicotine and caffeine), intake of antipsychotic and antidepressive drugs;
  • Proton pump inhibitors usage;
  • The use of antibiotics and/or probiotics 4 weeks prior to the study;
  • Glucocorticosteroids and/or metformin treatment;
  • Dietary supplementation (except for vitamin D) within the three months before screening;
  • Specific restrictive (e.g. elimination, vegan, FODMAP, reduction) diet within the three months before screening;
  • Significant changes in physical activity 4 weeks before the trial entry;
  • Pregnancy or lactation;
  • Significant GI surgery within the last 6 months prior to or planned during the study;
  • Any other medication for management of IBS complaints like peppermint oil, bile acid binders;
  • Lactose intolerance;
  • Participation in another study during the last 30 days prior to and during the study;
  • Any other reason for exclusion as per investigator's judgment, e.g. insufficient compliance with study procedures.

Treatment and study plan

Pasteurized Akkermansia muciniphila

Dietary Supplement

PAM supplementation; packaging will be given to the subjects every one month during follow-up visits, with the instructions to take one dose every morning on an empty stomach

Other names: PAM

Placebo

Dietary Supplement

PBO administration; packaging will be given to the subjects every one month during follow-up visits, with the instructions to take one dose every morning on an empty stomach

Other names: PBO

Primary outcomes

  1. Stress intensity

    Time frame: baseline

    serum dehydroepiandrosterone sulfate (DHEAS) in blood

  2. Stress intensity

    Time frame: 1 month

    serum dehydroepiandrosterone sulfate (DHEAS) in blood

  3. Stress intensity

    Time frame: 3 months

    serum dehydroepiandrosterone sulfate (DHEAS) in blood

  4. Cardiovascular marker of stressor intensity

    Time frame: baseline

    blood pressure

  5. Cardiovascular marker of stressor intensity

    Time frame: 1 month

    blood pressure

  6. Cardiovascular marker of stressor intensity

    Time frame: 3 months

    blood pressure

  7. Cardiovascular marker of stressor intensity

    Time frame: baseline

    heart rate

  8. Cardiovascular marker of stressor intensity

    Time frame: 1 month

    heart rate

  9. Cardiovascular marker of stressor intensity

    Time frame: 3 months

    heart rate

  10. Stress intensity

    Time frame: baseline

    Perceived Stress Scale (PSS-10). Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.

  11. Stress intensity

    Time frame: 1 month

    Perceived Stress Scale (PSS-10). Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.

  12. Stress intensity

    Time frame: 3 months

    Perceived Stress Scale (PSS-10). Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.

  13. Psychosocial working conditions

    Time frame: baseline

    Copenhagen Psychosocial Questionnaire (COPSOQ). The scales of the COPSOQ are formed by adding the points of the individual questions of the scales by giving equal weights to each question. In most cases the questions have five response options. In these cases the weights are: 0, 25, 50, 75, and 100. The scale value is calculated as the simple average

  14. Psychosocial working conditions

    Time frame: 1 month

    Copenhagen Psychosocial Questionnaire (COPSOQ). The scales of the COPSOQ are formed by adding the points of the individual questions of the scales by giving equal weights to each question. In most cases the questions have five response options. In these cases the weights are: 0, 25, 50, 75, and 100. The scale value is calculated as the simple average

  15. Psychosocial working conditions

    Time frame: 3 months

    Copenhagen Psychosocial Questionnaire (COPSOQ). The scales of the COPSOQ are formed by adding the points of the individual questions of the scales by giving equal weights to each question. In most cases the questions have five response options. In these cases the weights are: 0, 25, 50, 75, and 100. The scale value is calculated as the simple average

  16. The recognition of the most common mental disorders

    Time frame: baseline

    Primary Care Evaluation of Mental Disorders (PRIME-MD). The yes/no questionnaire serves as an initial screen for 5 general groups of mental disorders commonly found in the general population

  17. The recognition of the most common mental disorders

    Time frame: 1 month

    Primary Care Evaluation of Mental Disorders (PRIME-MD). The yes/no questionnaire serves as an initial screen for 5 general groups of mental disorders commonly found in the general population

  18. The recognition of the most common mental disorders

    Time frame: 3 months

    Primary Care Evaluation of Mental Disorders (PRIME-MD). The yes/no questionnaire serves as an initial screen for 5 general groups of mental disorders commonly found in the general population

  19. Depression

    Time frame: baseline

    Patient Health Questionnaire-9 (PHQ-9). Nine items, each of which is scored 0 to 3, providing a 0 to 27 severity score.This score can then be referred to the accompanying PHQ-9 Scoring Box to interpret the TOTAL score.

  20. Depression

    Time frame: 1 month

    Patient Health Questionnaire-9 (PHQ-9). Nine items, each of which is scored 0 to 3, providing a 0 to 27 severity score.This score can then be referred to the accompanying PHQ-9 Scoring Box to interpret the TOTAL score.

  21. Depression

    Time frame: 3 months

    Patient Health Questionnaire-9 (PHQ-9). Nine items, each of which is scored 0 to 3, providing a 0 to 27 severity score.This score can then be referred to the accompanying PHQ-9 Scoring Box to interpret the TOTAL score.

  22. Depressive state

    Time frame: baseline

    The Beck Depression Inventory (BDI). When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. The standard cut-off scores were as follows:

    0-18: indicates minimal depression 18-30: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression.

  23. Depressive state

    Time frame: 1 month

    The Beck Depression Inventory (BDI). When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. The standard cut-off scores were as follows:

    0-18: indicates minimal depression 18-30: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression.

  24. Depressive state

    Time frame: 3 months

    The Beck Depression Inventory (BDI). When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. The standard cut-off scores were as follows:

    0-18: indicates minimal depression 18-30: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression.

  25. Anxiety and stress

    Time frame: baseline

    Depression Anxiety Stress Scale 21 (DASS-21). This is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. The rating scale is as follows:

    0 - Did not apply to me at all

    • - Applied to me to some degree, or some of the time
    • - Applied to me to a considerable degree, or a good part of time
    • - Applied to me very much, or most of the time.

    SUBSCALES:

    DASS_Anxiety = questions 2 + 4 + 7 + 9 + 15 + 19 + 20

    DASS_Depression = questions 3 + 5 + 10 + 13 + 16 + 17 + 21

    DASS_Stress = questions 1 + 6 + 8 + 11 + 12 + 14 +18

  26. Anxiety and stress

    Time frame: 1 month

    Depression Anxiety Stress Scale 21 (DASS-21). This is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. The rating scale is as follows:

    0 - Did not apply to me at all

    • - Applied to me to some degree, or some of the time
    • - Applied to me to a considerable degree, or a good part of time
    • - Applied to me very much, or most of the time.

    SUBSCALES:

    DASS_Anxiety = questions 2 + 4 + 7 + 9 + 15 + 19 + 20

    DASS_Depression = questions 3 + 5 + 10 + 13 + 16 + 17 + 21

    DASS_Stress = questions 1 + 6 + 8 + 11 + 12 + 14 +18

  27. Anxiety and stress

    Time frame: 3 months

    Depression Anxiety Stress Scale 21 (DASS-21). This is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. The rating scale is as follows:

    0 - Did not apply to me at all

    • - Applied to me to some degree, or some of the time
    • - Applied to me to a considerable degree, or a good part of time
    • - Applied to me very much, or most of the time.

    SUBSCALES:

    DASS_Anxiety = questions 2 + 4 + 7 + 9 + 15 + 19 + 20

    DASS_Depression = questions 3 + 5 + 10 + 13 + 16 + 17 + 21

    DASS_Stress = questions 1 + 6 + 8 + 11 + 12 + 14 +18

  28. Occurrence of Irritable Bowel Syndrome

    Time frame: baseline

    Rome IV criteria

  29. Occurrence of Irritable Bowel Syndrome

    Time frame: 1 month

    Rome IV criteria

  30. Occurrence of Irritable Bowel Syndrome

    Time frame: 3 months

    Rome IV criteria

  31. Occurence and severity of gastrointestinal symptoms

    Time frame: baseline

    Gastrointestinal Symptom Rating Scale (GSRS)

  32. Occurence and severity of gastrointestinal symptoms

    Time frame: 1 month

    Gastrointestinal Symptom Rating Scale (GSRS)

  33. Occurence and severity of gastrointestinal symptoms

    Time frame: 3 months

    Gastrointestinal Symptom Rating Scale (GSRS)

Secondary outcomes

  1. Microbiota composition

    Time frame: baseline

    next generation sequencing

  2. Microbiota composition

    Time frame: 1 month

    next generation sequencing

  3. Microbiota composition

    Time frame: 3 months

    next generation sequencing

  4. A. muciniphila count in stool

    Time frame: baseline

    real-time quantitative PCR (qPCR)

  5. A. muciniphila count in stool

    Time frame: 1 month

    real-time quantitative PCR (qPCR)

  6. A. muciniphila count in stool

    Time frame: 3 months

    real-time quantitative PCR (qPCR)

  7. Total bacteria count in stool

    Time frame: baseline

    real-time quantitative PCR (qPCR)

  8. Total bacteria count in stool

    Time frame: 1 month

    real-time quantitative PCR (qPCR)

  9. Total bacteria count in stool

    Time frame: 3 months

    real-time quantitative PCR (qPCR)

  10. Short chain fatty acids content in stool

    Time frame: baseline

    quadrupole mass spectrometer and high performance liquid chromatograph

  11. Short chain fatty acids content in stool

    Time frame: 1 month

    quadrupole mass spectrometer and high performance liquid chromatograph

  12. Short chain fatty acids content in stool

    Time frame: 3 months

    quadrupole mass spectrometer and high performance liquid chromatograph

  13. Immune phenotypes of peripheral blood mononuclear cells (PBMCs)

    Time frame: baseline

    single-cell genomics (scRNA-seq and scATAC-seq) analyses (in blood)

  14. Immune phenotypes of peripheral blood mononuclear cells (PBMCs)

    Time frame: 1 month

    single-cell genomics (scRNA-seq and scATAC-seq) analyses (in blood)

  15. Immune phenotypes of peripheral blood mononuclear cells (PBMCs)

    Time frame: 3 months

    single-cell genomics (scRNA-seq and scATAC-seq) analyses (in blood)

  16. Inflammatory mediators concentrations in blood

    Time frame: baseline

    high-throughput protein biomarker analysis with the advent of Proximity Extension Assay

  17. Inflammatory mediators concentrations in blood

    Time frame: 1 month

    high-throughput protein biomarker analysis with the advent of Proximity Extension Assay

  18. Inflammatory mediators concentrations in blood

    Time frame: 3 months

    high-throughput protein biomarker analysis with the advent of Proximity Extension Assay

  19. Zonulin concentration in stool

    Time frame: baseline

    enzyme-linked immunosorbent assay (ELISA)

  20. Zonulin concentration in stool

    Time frame: 1 month

    enzyme-linked immunosorbent assay (ELISA)

  21. Zonulin concentration in stool

    Time frame: 3 months

    enzyme-linked immunosorbent assay (ELISA)

  22. Calprotectin concentration in stool

    Time frame: baseline

    enzyme-linked immunosorbent assay (ELISA)

  23. Calprotectin concentration in stool

    Time frame: 1 month

    enzyme-linked immunosorbent assay (ELISA)

  24. Calprotectin concentration in stool

    Time frame: 3 months

    enzyme-linked immunosorbent assay (ELISA)

  25. Lipopolysaccharide concentration in blood

    Time frame: baseline

    enzyme-linked immunosorbent assay (ELISA)

  26. Lipopolysaccharide concentration in blood

    Time frame: 1 month

    enzyme-linked immunosorbent assay (ELISA)

  27. Lipopolysaccharide concentration in blood

    Time frame: 3 months

    enzyme-linked immunosorbent assay (ELISA)

  28. Adiposity

    Time frame: baseline

    Fat mass/fat free mass evaluated by bioimpedance

  29. Adiposity

    Time frame: 1 month

    Fat mass/fat free mass evaluated by bioimpedance

  30. Adiposity

    Time frame: 3 months

    Fat mass/fat free mass evaluated by bioimpedance

  31. Obesity

    Time frame: baseline

    Body weight

  32. Obesity

    Time frame: 1 month

    Body weight

  33. Obesity

    Time frame: 3 months

    Body weight

  34. Dietary habits

    Time frame: baseline

    the frequency of certain food consumption (rank score) by means of validated Food Frequency Questionnaire (FFQ).

  35. Physical activity

    Time frame: baseline

    International Physical Activity Questionnaire. Results can be reported in categories (low activity levels, moderate activity levels or high activity levels) or as a continuous variable (MET minutes a week).

  36. Functions of peripheral blood mononuclear cells (PBMCs)

    Time frame: baseline

    mass cytometry (CyTOF)

  37. Functions of peripheral blood mononuclear cells (PBMCs)

    Time frame: 1 month

    mass cytometry (CyTOF)

  38. Functions of peripheral blood mononuclear cells (PBMCs)

    Time frame: 3 months

    mass cytometry (CyTOF)

  39. Insulin resistance

    Time frame: baseline

    HOMA-Homeostasis Model Assessment calculated from fasted glycemia and insulinemia

  40. Insulin resistance

    Time frame: 1 month

    HOMA-Homeostasis Model Assessment calculated from fasted glycemia and insulinemia

  41. Insulin resistance

    Time frame: 3 months

    HOMA-Homeostasis Model Assessment calculated from fasted glycemia and insulinemia

  42. carbohydrate metabolism

    Time frame: baseline

    glycated hemoglobin (HbA1c)

  43. carbohydrate metabolism

    Time frame: 1 month

    glycated hemoglobin (HbA1c)

  44. carbohydrate metabolism

    Time frame: 3 months

    glycated hemoglobin (HbA1c)

  45. Concentration of blood lipids

    Time frame: baseline

    Analysis of circulating lipids : total, LDL and HDL cholesterol (mg/dl), triglycerides (md/dl)

  46. Concentration of blood lipids

    Time frame: 1 month

    Analysis of circulating lipids : total, LDL and HDL cholesterol (mg/dl), triglycerides (md/dl)

  47. Concentration of blood lipids

    Time frame: 3 months

    Analysis of circulating lipids : total, LDL and HDL cholesterol (mg/dl), triglycerides (md/dl)

Sponsors and collaborators

Lead sponsor

Pomeranian Medical University Szczecin

Other

Collaborators

  • Charite University, Berlin, Germany
  • Imperial College London
  • MAX DELBRUECK CENTRUM FUER MOLEKULARE MEDIZIN IN DER HELMHOLTZ-GEMEINSCHAFT (MDC) - MDC
  • SANPROBI SPOLKA Z OGRANICZONA ODPOWIEDZIALNOSCIA SPOLKA KOMANDYTOWA
  • THE AKKERMANSIA COMPANY

Registry information

Official study title

The Effects of the Anti-inflammatory Microbe - Pasteurized Akkermansia Muciniphila (PAM) on Symptoms of Somatic and Mental Stress in Healthcare Professionals

Acronym: MENTAkHEALTH

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 22, 2023
Registry last updated
Mar 18, 2025

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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