The Effect of Probiotic Supplementation on Mental Health in Healthy Volunteers (ProBeMent)

July 11, 2024 updated by: Michal Karbownik, Medical University of Lodz

The Effect of Supplementation With Lactobacillus Helveticus R0052 and Bifidobacterium Longum R0175 Combination Probiotic on Mental Health Indices and Oral Microbiota Status in Healthy Volunteers Facing a Stressful Event

Probiotics are "live microorganisms which when administered in adequate amounts confer a health benefit on the host". Accumulating evidence indicates their effect in mental health restoration. Beneficial neuropsychological and psychobiological effects are particularly well substantiated in clinical samples. However, it is not clearly documented whether probiotic supplementation reduces depressive and anxiety symptoms in healthy volunteers experiencing temporal deterioration in mental functioning while facing a stressful event. The combination of Lactobacillus helveticus R0052 and Bifidobacterium longum R0175 is particularly well studied in terms of its central nervous system action with significantly deciphered mechanism. As a result, this combination is particularly promising to study the effect of mental health improvement in healthy volunteers facing a stressful event.

The aim of this project is to assess the impact of a 8-week supplementation with probiotic combination of Lactobacillus helveticus R0052 and Bifidobacterium longum R0175 strains in the daily dose of 3 × 10^9 colony forming units on mental health measures and oral microbiota composition and metabolome in healthy young adults facing a psychologically stressful event. The aim will be achieved by comparing the probiotic combination supplement to placebo in a randomized triple-blind controlled trial settings with a participant allocation ratio of 1:1.

The summer academic examination session and the upcoming first take of the final exam in pharmacology at third year of medical studies will be a model of a stressful event. The participants will supplement their diets with probiotic/placebo for 8 weeks before the exam. After giving written informed consent, before the supplementation (relatively stress-free time period in terms of academic activities) the participants will provide background sociodemographic, anthropometric and psychometric data. At that time, participants will also give samples of saliva to assess cortisol and selected cytokines concentrations as well as salivary microbiome and metabolome. At the end of supplementation, a day before the final exam, participants will donate salivary samples and do psychometric tests for the second time to assess the same parameters as at the beginning of the study. Participants will also do a pre-exam test in pharmacology (not considered a formal academic assessment) as a comparator for the results of the formal examination held a day after.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Łódź, Poland
        • Medical University of Lodz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • status of a third-year medical student at the Faculty of Medicine of the Medical University of Lodz
  • age (18-30 years)
  • high motivation and no formal obstacles to sit the first take of the final exam in pharmacology
  • Body mass index of 18-25 kg/m2

Exclusion Criteria:

  • chronic dental diseases (in particular periodontal diseases), neurological, psychiatric, cardiological, gastroenterological, endocrinological, immunological, inflammatory or infectious diseases or disorders
  • psychiatric or neurological diagnosis - within the last 1 year
  • immune disorders or possible immunodeficiency - within the last 5 years
  • previous bariatric surgery - within the last 5 years
  • hospitalization - within the last 3 months
  • presence of central venous catheters
  • use of enteral nutrition (feeding tube or nutritional fistula)
  • pregnant or planning to become pregnant in the next 3 months
  • breast-feeding
  • occurrence of an allergic reaction - within the last 3 months
  • hypersensitivity to potato starch or magnesium stearate
  • chronic use of any medicinal products - within the last 3 months
  • use of systemic antibacterial or antifungal drugs - within the last 1 month
  • alcohol abuse (≥ 20 g or ≥ 40 g of alcohol per day for women and men, respectively) - within the last 3 months
  • abuse of narcotic or psychotropic substances - within the last 3 months
  • regular smoking of tobacco or other nicotine products, including e-cigarettes (> 5 cigarettes or equivalents per day - within the last 3 months)
  • use of probiotic or prebiotic preparations - within the last 1 month
  • a vegan diet or any unusual diet

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Probiotic
Lactobacillus helveticus R0052 and Bifidobacterium longum R0175 combination probiotic - encapsulated
Dietary supplement: Lactobacillus helveticus R0052 and Bifidobacterium longum R0175
8-week supplementation (56 days); 3 × 10^9 CFU/day
Placebo Comparator: Placebo
Mixture of potato starch and magnesium stearate (the excipients that are present in the tested product) - encapsulated
Dietary supplement: Placebo
8-week supplementation (56 days)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cortisol
Time Frame: Day 0, Day 55
Salivary cortisol level measured with ELISA test
Day 0, Day 55
Depression symptoms under examination-related stress
Time Frame: Day 0, Day 55
Depression symptoms measured with Depression Anxiety Stress Scale - 21 (DASS-21). Seven items, each scored 0 to 3 points, yielding a total between 0 and 21 points. The more points the more severe depression.
Day 0, Day 55
Anxiety symptoms under examination-related stress
Time Frame: Day 0, Day 55
Anxiety symptoms measured with Depression Anxiety Stress Scale - 21 (DASS-21). Seven items, each scored 0 to 3 points, yielding a total between 0 and 21 points. The more points the more severe anxiety.
Day 0, Day 55
Stress symptoms under examination-related stress
Time Frame: Day 0, Day 55
Stress symptoms measured with Depression Anxiety Stress Scale - 21 (DASS-21). Seven items, each scored 0 to 3 points, yielding a total between 0 and 21 points. The more points the more severe stress.
Day 0, Day 55
Performance under examination-related stress
Time Frame: Day 56
Number of correctly-answered questions in the final examination in pharmacology in relation to subject knowledge assessed in the pre-exam test. 60 questions, each scored 0 or 1 point, yielding a total between 0 and 60 points. The more points the better performance under examination-related stress.
Day 56

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interleukin-1β (IL-1β)
Time Frame: Day 0, Day 55
Salivary IL-1β level measured with ELISA test in relation to total protein concentration in saliva
Day 0, Day 55
Interleukin-8 (IL-8)
Time Frame: Day 0, Day 55
Salivary IL-8 level measured with ELISA test in relation to total protein concentration in saliva
Day 0, Day 55
Microbiome
Time Frame: Day 0, Day 55
Salivary microbiome assessed with 16S rRNA gene sequencing
Day 0, Day 55
Metabolome
Time Frame: Day 0, Day 55
Salivary metabolome assessed with liquid chromatography-mass spectrometry
Day 0, Day 55
Sleep quality under examination-related stress
Time Frame: Day 0, Day 55
Sleep quality status measured with Pittsburgh Sleep Quality Index (PSQI). Seven components, each scored 0 to 3 points, yielding a total composite score of 0 to 21 points. The more points the more sleep difficulties.
Day 0, Day 55
Fatigue under examination-related stress
Time Frame: Day 0, Day 55
Fatigue status measured with Fatigue Severity Scale (FSS). Nine items, each scored 1 to 7 points, yielding a total between 7 and 63 points. The more points the greater fatigue severity.
Day 0, Day 55
Mood
Time Frame: Day 0, Day 55
Current mood measured with a pictogram-enhanced visual analog mood scale. A single item scored 0 to 10 points, yielding a total between 0 and 10 points. The more points the better mood.
Day 0, Day 55
Depression symptoms under examination-related stress (supportive measure)
Time Frame: Day 0, Day 55
Depression symptoms measured with Patient Health Questionnaire - 9 (PHQ-9). Nine items, each scored 0 to 3 points, yielding a total between 0 and 27 points. The more points the more severe depression.
Day 0, Day 55
Anxiety symptoms under examination-related stress (supportive measure)
Time Frame: Day 0, Day 55
Anxiety symptoms measured with General Anxiety Disorder - 7 (GAD-7). Seven items, each scored 0 to 3 points, yielding a total between 0 and 21 points. The more points the more severe anxiety.
Day 0, Day 55

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Lodz

Collaborators

Pomeranian Medical University Szczecin
SANPROBI Sp. z o.o. Sp.k.

Investigators

  • Study Chair: Michał S. Karbownik, PhD, Medical University of Lodz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2024

Primary Completion (Actual)

July 5, 2024

Study Completion (Actual)

July 5, 2024

Study Registration Dates

First Submitted

April 23, 2024

First Submitted That Met QC Criteria

April 25, 2024

First Posted (Actual)

April 30, 2024

Study Record Updates

Last Update Posted (Actual)

July 12, 2024

Last Update Submitted That Met QC Criteria

July 11, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ProBeMent

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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