The Efficacy of Pasteurised Akkermansia Muciniphila in Healthy Medical Workers

NCT05738746 | Completed DMC

• 1 other identifier: 101095540
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Stress; Healthy; Dietary Supplement

Keywords

microbiota; postbiotic; stress; metabolome; immunometabolism

Outcome Measures

Primary Outcomes (33)

• Stress intensity

  serum dehydroepiandrosterone sulfate (DHEAS) in blood

  baseline

• Stress intensity

  serum dehydroepiandrosterone sulfate (DHEAS) in blood

  1 month

• Stress intensity

  serum dehydroepiandrosterone sulfate (DHEAS) in blood

  3 months

• Cardiovascular marker of stressor intensity

  blood pressure

  baseline

• Cardiovascular marker of stressor intensity

  blood pressure

  1 month

• Cardiovascular marker of stressor intensity

  blood pressure

  3 months

• Cardiovascular marker of stressor intensity

  heart rate

  baseline

• Cardiovascular marker of stressor intensity

  heart rate

  1 month

• Cardiovascular marker of stressor intensity

  heart rate

  3 months

• Stress intensity

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

  baseline

• Stress intensity

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

  1 month

• Stress intensity

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

  3 months

• Psychosocial working conditions

  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

  baseline

• Psychosocial working conditions

  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

  1 month

• Psychosocial working conditions

  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

  3 months

• The recognition of the most common mental disorders

  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

  baseline

• The recognition of the most common mental disorders

  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

  1 month

• The recognition of the most common mental disorders

  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

  3 months

• Depression

  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.

  baseline

• Depression

  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.

  1 month

• Depression

  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.

  3 months

• Depressive state

  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.

  baseline

• Depressive state

  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.

  1 month

• Depressive state

  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.

  3 months

• Anxiety and stress

  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 1. \- Applied to me to some degree, or some of the time 2. \- Applied to me to a considerable degree, or a good part of time 3. \- 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

  baseline

• Anxiety and stress

  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 1. \- Applied to me to some degree, or some of the time 2. \- Applied to me to a considerable degree, or a good part of time 3. \- 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

  1 month

• Anxiety and stress

  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 1. \- Applied to me to some degree, or some of the time 2. \- Applied to me to a considerable degree, or a good part of time 3. \- 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

  3 months

• Occurrence of Irritable Bowel Syndrome

  Rome IV criteria

  baseline

• Occurrence of Irritable Bowel Syndrome

  Rome IV criteria

  1 month

• Occurrence of Irritable Bowel Syndrome

  Rome IV criteria

  3 months

• Occurence and severity of gastrointestinal symptoms

  Gastrointestinal Symptom Rating Scale (GSRS)

  baseline

• Occurence and severity of gastrointestinal symptoms

  Gastrointestinal Symptom Rating Scale (GSRS)

  1 month

• Occurence and severity of gastrointestinal symptoms

  Gastrointestinal Symptom Rating Scale (GSRS)

  3 months

Secondary Outcomes (47)

• Microbiota composition

  baseline

• Microbiota composition

  1 month

• Microbiota composition

  3 months

• A. muciniphila count in stool

  baseline

• A. muciniphila count in stool

  1 month

Study Arms (2)

Pasteurized Akkermansia muciniphila

EXPERIMENTAL

pasteurized A.muciniphila (Pasteurized, 3x10\^10 bacteria per day) as supplement for 3 months,

Dietary Supplement: Pasteurized Akkermansia muciniphila

Placebo

PLACEBO COMPARATOR

placebo administered for 3 months once a day

Dietary Supplement: Placebo

Interventions

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

Also known as: PAM

Pasteurized Akkermansia muciniphila

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

Also known as: PBO

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

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

Study Sites (2)

Pomeranian Medical University in Szczecin

Szczecin, West Pomeranian Voivodeship, 70-210, Poland

Location

Center fo Medical Simulation

Szczecin, West Pomeranian Voivodeship, 71-240, Poland

Location

Related Publications (4)

• Depommier C, Everard A, Druart C, Plovier H, Van Hul M, Vieira-Silva S, Falony G, Raes J, Maiter D, Delzenne NM, de Barsy M, Loumaye A, Hermans MP, Thissen JP, de Vos WM, Cani PD. Supplementation with Akkermansia muciniphila in overweight and obese human volunteers: a proof-of-concept exploratory study. Nat Med. 2019 Jul;25(7):1096-1103. doi: 10.1038/s41591-019-0495-2. Epub 2019 Jul 1.

  PMID: 31263284 BACKGROUND

• Schneeberger M, Everard A, Gomez-Valades AG, Matamoros S, Ramirez S, Delzenne NM, Gomis R, Claret M, Cani PD. Akkermansia muciniphila inversely correlates with the onset of inflammation, altered adipose tissue metabolism and metabolic disorders during obesity in mice. Sci Rep. 2015 Nov 13;5:16643. doi: 10.1038/srep16643.

  PMID: 26563823 BACKGROUND

• Druart C, Plovier H, Van Hul M, Brient A, Phipps KR, de Vos WM, Cani PD. Toxicological safety evaluation of pasteurized Akkermansia muciniphila. J Appl Toxicol. 2021 Feb;41(2):276-290. doi: 10.1002/jat.4044. Epub 2020 Jul 28.

  PMID: 32725676 BACKGROUND

• Cani PD, Depommier C, Derrien M, Everard A, de Vos WM. Akkermansia muciniphila: paradigm for next-generation beneficial microorganisms. Nat Rev Gastroenterol Hepatol. 2022 Oct;19(10):625-637. doi: 10.1038/s41575-022-00631-9. Epub 2022 May 31.

  PMID: 35641786 BACKGROUND

Related Links

• EC official website with research results

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Sequentially numbered drug containers of identical appearance
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: parallel-groups, randomized, placebo-controlled clinical study

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 22, 2023
• Study Start: October 24, 2023
• Primary Completion: March 10, 2025
• Study Completion: March 10, 2025
• Last Updated: March 18, 2025

Record last verified: 2025-03

Locations

PL (2)