Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06391216
Status:
COMPLETED
Last Update Posted:
2024-07-12
First Post:
2024-04-23
Brief Title:
The Effect of Probiotic Supplementation on Mental Health in Healthy Volunteers
Sponsor:
Medical University of Lodz
Organization:
Medical University of Lodz
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ProBeMent
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 3 109 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 11
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 probioticplacebo 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
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 3 109 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 11
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 probioticplacebo 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None