RecruitingNot ApplicableNCT07779265

Effects of Probiotic Supplementation on Gut Health, Immune Response, and Well-Being

Randomized, Double-Blind, Placebo-Controlled Exploratory Study Assessing the Effects of Probiotic Supplementation on Gut Barrier Function, Immune Response, and Well-Being.


Sponsor

Orthomol Pharmazeutische Vertiebs GmbH

Enrollment

50 participants

Start Date

Aug 13, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This randomized, double-blind, placebo-controlled exploratory study will evaluate the effects of daily probiotic supplementation on gut barrier function, immune-related markers, and well-being in healthy adults with mild to moderate perceived stress. 50 participants will be randomly assigned to receive either a probiotic supplement or placebo for 8 weeks. Blood and stool samples will be collected before and after the intervention to assess markers of gut barrier function, intestinal inflammation, gut microbiome composition, short-chain fatty acids, and immune function. Participants will also complete questionnaires on stress, quality of life, mood, digestive symptoms, and bowel habits. Safety will be evaluated throughout the study by monitoring adverse events and vital sign assessments.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Placebo and Probiotic capsules for people with gut microbiome, immune responses, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTProbiotic capsules

Fructooligosaccharides, selected probiotic strains, vitamins

OTHERPlacebo

Maltodextrin, corn starch


Locations(1)

daacro GmbH & Co.KG

Trier, Germany

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NCT07779265


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