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Effects of Probiotic Supplementation on Gut Health, Immune Response, and Well-Being
Sponsor: Orthomol Pharmazeutische Vertiebs GmbH
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.
Official title: Randomized, Double-Blind, Placebo-Controlled Exploratory Study Assessing the Effects of Probiotic Supplementation on Gut Barrier Function, Immune Response, and Well-Being.
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2026-08-13
Completion Date
2026-12
Last Updated
2026-08-21
Healthy Volunteers
Yes
Conditions
Interventions
Probiotic capsules
Fructooligosaccharides, selected probiotic strains, vitamins
Placebo
Maltodextrin, corn starch
Locations (1)
daacro GmbH & Co.KG
Trier, Germany