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RECRUITING
NCT07779265
NA

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

Sponsor: Orthomol Pharmazeutische Vertiebs GmbH

View on ClinicalTrials.gov

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

Interventions

DIETARY_SUPPLEMENT

Probiotic capsules

Fructooligosaccharides, selected probiotic strains, vitamins

OTHER

Placebo

Maltodextrin, corn starch

Locations (1)

daacro GmbH & Co.KG

Trier, Germany