HealthyProBeMentNCT06391216
The Effect of Probiotic Supplementation on Mental Health in Healthy Volunteers
A study testing Lactobacillus helveticus R0052 and Bifidobacterium longum R0175 in people with Healthy and Stress-related Problem, run by Medical University of Lodz at 1 site in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Stress-related Problem, Depression
- What is being tested?
- Lactobacillus helveticus R0052 and Bifidobacterium longum R0175
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 6 May 2024to 5 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy, Stress-related Problem, Depression, Anxiety
- Being tested
- Lactobacillus helveticus R0052 and Bifidobacterium longum R0175, Placebo
- Keywords
- Probiotics, Academic examination, Psychological stress, Depression, Anxiety
- Medical subject headings
- Depression, Anxiety Disorders, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus helveticus R0052 and Bifidobacterium longum R0175Dietary supplement
8-week supplementation (56 days); 3 × 10^9 CFU/day
PlaceboDietary supplement
8-week supplementation (56 days)
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Lactobacillus helveticus R0052 and Bifidobacterium longum R0175 combination probiotic - encapsulated Receives: Dietary Supplement: Lactobacillus helveticus R0052 and Bifidobacterium longum R0175 |
| Placebo | Placebo comparator | Mixture of potato starch and magnesium stearate (the excipients that are present in the tested product) - encapsulated Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortisol
Salivary cortisol level measured with ELISA test
Measured: Day 0, Day 55
Depression symptoms under examination-related stress
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.
Measured: Day 0, Day 55
Anxiety symptoms under examination-related stress
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.
Measured: Day 0, Day 55
Stress symptoms under examination-related stress
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.
Measured: Day 0, Day 55
Performance under examination-related stress
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.
Measured: Day 56
Secondary outcomes (9)
Interleukin-1β (IL-1β)
Salivary IL-1β level measured with ELISA test in relation to total protein concentration in saliva
Measured: Day 0, Day 55
Interleukin-8 (IL-8)
Salivary IL-8 level measured with ELISA test in relation to total protein concentration in saliva
Measured: Day 0, Day 55
Microbiome
Salivary microbiome assessed with 16S rRNA gene sequencing
Measured: Day 0, Day 55
Metabolome
Salivary metabolome assessed with liquid chromatography-mass spectrometry
Measured: Day 0, Day 55
Mood
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.
Measured: Day 0, Day 55
Depression symptoms under examination-related stress (supportive measure)
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.
Measured: Day 0, Day 55
Anxiety symptoms under examination-related stress (supportive measure)
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.
Measured: Day 0, Day 55
Sleep quality under examination-related stress
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.
Measured: Day 0, Day 55
Fatigue under examination-related stress
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.
Measured: Day 0, Day 55
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start6 May 2024
- Primary completion5 Jul 2024
- Study completion5 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Healthy medical students are assigned
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Collaborators
- Pomeranian Medical University Szczecin, SANPROBI Sp. z o.o. Sp.k.
- Responsible party
- Principal investigator, Michal Karbownik, Medical University of Lodz
- Investigators
- Michał S. Karbownik, PhD, Study chair, Medical University of Lodz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06391216
- Sponsor's protocol ID
- ProBeMent
- Acronym
- ProBeMent
- Status last verified
- Jul 2024
- First submitted
- 23 Apr 2024
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Messaoudi M, Lalonde R, Violle N, Javelot H, Desor D, Nejdi A, Bisson JF, Rougeot C, Pichelin M, Cazaubiel M, Cazaubiel JM. Assessment of psychotropic-like properties of a probiotic formulation (Lactobacillus helveticus R0052 and Bifidobacterium longum R0175) in rats and human subjects. Br J Nutr. 2011 Mar;105(5):755-64. doi: 10.1017/S0007114510004319. Epub 2010 Oct 26.
PubMed 20974015Ait-Belgnaoui A, Colom A, Braniste V, Ramalho L, Marrot A, Cartier C, Houdeau E, Theodorou V, Tompkins T. Probiotic gut effect prevents the chronic psychological stress-induced brain activity abnormality in mice. Neurogastroenterol Motil. 2014 Apr;26(4):510-20. doi: 10.1111/nmo.12295. Epub 2013 Dec 30.
PubMed 24372793Ait-Belgnaoui A, Payard I, Rolland C, Harkat C, Braniste V, Theodorou V, Tompkins TA. Bifidobacterium longum and Lactobacillus helveticus Synergistically Suppress Stress-related Visceral Hypersensitivity Through Hypothalamic-Pituitary-Adrenal Axis Modulation. J Neurogastroenterol Motil. 2018 Jan 30;24(1):138-146. doi: 10.5056/jnm16167.
PubMed 29291614Chao L, Liu C, Sutthawongwadee S, Li Y, Lv W, Chen W, Yu L, Zhou J, Guo A, Li Z, Guo S. Effects of Probiotics on Depressive or Anxiety Variables in Healthy Participants Under Stress Conditions or With a Depressive or Anxiety Diagnosis: A Meta-Analysis of Randomized Controlled Trials. Front Neurol. 2020 May 22;11:421. doi: 10.3389/fneur.2020.00421. eCollection 2020.
PubMed 32528399Karbownik MS, Kreczynska J, Kwarta P, Cybula M, Wiktorowska-Owczarek A, Kowalczyk E, Pietras T, Szemraj J. Effect of Supplementation with Saccharomyces Boulardii on Academic Examination Performance and Related Stress in Healthy Medical Students: A Randomized, Double-Blind, Placebo-Controlled Trial. Nutrients. 2020 May 19;12(5):1469. doi: 10.3390/nu12051469.
PubMed 32438624
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06391216
- Acronym / sponsor ID
- ProBeMent / ProBeMent
- Conditions
- Healthy, Stress-related Problem, Depression, Anxiety
- Keywords
- Probiotics, Academic examination, Psychological stress, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Collaborators
- Pomeranian Medical University Szczecin, SANPROBI Sp. z o.o. Sp.k.
- Study start
- 6 May 2024 (actual)
- Primary completion
- 5 Jul 2024 (actual)
- Study completion
- 5 Jul 2024 (actual)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Healthy medical students are assigned
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: Lactobacillus helveticus R0052 and Bifidobacterium longum R0175Lactobacillus helveticus R0052 and Bifidobacterium longum R0175 combination probiotic - encapsulated |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboMixture of potato starch and magnesium stearate (the excipients that are present in the tested product) - encapsulated |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus helveticus R0052 and Bifidobacterium longum R01758-week supplementation (56 days); 3 × 10^9 CFU/day | Dietary supplement | Probiotic |
| Placebo8-week supplementation (56 days) | Dietary supplement | Placebo |
Primary outcome
Cortisol
Time frame: Day 0, Day 55
Salivary cortisol level measured with ELISA test
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.
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.
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.
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.
9 secondary outcomes
Interleukin-1β (IL-1β)
Time frame: Day 0, Day 55
Interleukin-8 (IL-8)
Time frame: Day 0, Day 55
Microbiome
Time frame: Day 0, Day 55
Metabolome
Time frame: Day 0, Day 55
Mood
Time frame: Day 0, Day 55
Depression symptoms under examination-related stress (supportive measure)
Time frame: Day 0, Day 55
Anxiety symptoms under examination-related stress (supportive measure)
Time frame: Day 0, Day 55
Sleep quality under examination-related stress
Time frame: Day 0, Day 55
Fatigue under examination-related stress
Time frame: Day 0, Day 55
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Background: PubMed 20974015Messaoudi M, Lalonde R, Violle N, Javelot H, Desor D, Nejdi A, Bisson JF, Rougeot C, Pichelin M, Cazaubiel M, Cazaubiel JM. Assessment of psychotropic-like properties of a probiotic formulation (Lactobacillus helveticus R0052 and Bifidobacterium longum R0175) in rats and human subjects. Br J Nutr. 2011 Mar;105(5):755-64. doi: 10.1017/S0007114510004319. Epub 2010 Oct 26.
- Background: PubMed 24372793Ait-Belgnaoui A, Colom A, Braniste V, Ramalho L, Marrot A, Cartier C, Houdeau E, Theodorou V, Tompkins T. Probiotic gut effect prevents the chronic psychological stress-induced brain activity abnormality in mice. Neurogastroenterol Motil. 2014 Apr;26(4):510-20. doi: 10.1111/nmo.12295. Epub 2013 Dec 30.
- Background: PubMed 29291614Ait-Belgnaoui A, Payard I, Rolland C, Harkat C, Braniste V, Theodorou V, Tompkins TA. Bifidobacterium longum and Lactobacillus helveticus Synergistically Suppress Stress-related Visceral Hypersensitivity Through Hypothalamic-Pituitary-Adrenal Axis Modulation. J Neurogastroenterol Motil. 2018 Jan 30;24(1):138-146. doi: 10.5056/jnm16167.
- Background: PubMed 32528399Chao L, Liu C, Sutthawongwadee S, Li Y, Lv W, Chen W, Yu L, Zhou J, Guo A, Li Z, Guo S. Effects of Probiotics on Depressive or Anxiety Variables in Healthy Participants Under Stress Conditions or With a Depressive or Anxiety Diagnosis: A Meta-Analysis of Randomized Controlled Trials. Front Neurol. 2020 May 22;11:421. doi: 10.3389/fneur.2020.00421. eCollection 2020.
- Background: PubMed 32438624Karbownik MS, Kreczynska J, Kwarta P, Cybula M, Wiktorowska-Owczarek A, Kowalczyk E, Pietras T, Szemraj J. Effect of Supplementation with Saccharomyces Boulardii on Academic Examination Performance and Related Stress in Healthy Medical Students: A Randomized, Double-Blind, Placebo-Controlled Trial. Nutrients. 2020 May 19;12(5):1469. doi: 10.3390/nu12051469.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michał S. Karbownik, PhD study chair
Medical University of Lodz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus helveticus R0052 and Bifidobacterium longum R0175 in people with Healthy and Stress-related Problem, run by Medical University of Lodz at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cortisol (time frame: Day 0, Day 55). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06391216, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.