The Effect of Probiotic Supplementation on Mental Health in Healthy Volunteers

NCT06391216 | Completed

• 1 other identifier: ProBeMent
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Probiotics; Academic examination; Psychological stress; Depression; Anxiety

Outcome Measures

Primary Outcomes (5)

• Cortisol

  Salivary cortisol level measured with ELISA test

  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.

  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.

  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.

  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.

  Day 56

Secondary Outcomes (9)

• Interleukin-1β (IL-1β)

  Day 0, Day 55

• Interleukin-8 (IL-8)

  Day 0, Day 55

• Microbiome

  Day 0, Day 55

• Metabolome

  Day 0, Day 55

• Mood

  Day 0, Day 55

Study Arms (2)

Probiotic

EXPERIMENTAL

Lactobacillus helveticus R0052 and Bifidobacterium longum R0175 combination probiotic - encapsulated

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

Dietary Supplement: Placebo

Interventions

Lactobacillus helveticus R0052 and Bifidobacterium longum R0175 DIETARY_SUPPLEMENT

8-week supplementation (56 days); 3 × 10\^9 CFU/day

Probiotic

Placebo DIETARY_SUPPLEMENT

8-week supplementation (56 days)

Placebo

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Lodz: lead
• Pomeranian Medical University Szczecin: collaborator
• SANPROBI Sp. z o.o. Sp.k.: collaborator

Study Sites (1)

Medical University of Lodz

Lodz, Poland

Location

Related Publications (5)

• 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.

  PMID: 20974015 BACKGROUND

• Ait-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.

  PMID: 24372793 BACKGROUND

• Ait-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.

  PMID: 29291614 BACKGROUND

• Chao 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.

  PMID: 32528399 BACKGROUND

• Karbownik 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.

  PMID: 32438624 BACKGROUND

MeSH Terms

Conditions

Depression; Anxiety Disorders; Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Michał S. Karbownik, PhD

  Medical University of Lodz

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Healthy medical students are assigned

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: April 30, 2024
• Study Start: May 6, 2024
• Primary Completion: July 5, 2024
• Study Completion: July 5, 2024
• Last Updated: July 12, 2024

Record last verified: 2024-07

Locations

PL (1)