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

NCT07779265 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-08-21

No results posted yet for this study

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.

Conditions

  • Gut Microbiome
  • Immune Responses
  • Well-being

Interventions

DIETARY_SUPPLEMENT

Probiotic capsules

Fructooligosaccharides, selected probiotic strains, vitamins

OTHER

Placebo

Maltodextrin, corn starch

Sponsors & Collaborators

  • Daacro GmbH & Co. KG, Max-Planck-Str. 22, 54296 Trier/Germany

    collaborator UNKNOWN

  • Orthomol Pharmazeutische Vertiebs GmbH

    lead INDUSTRY

Principal Investigators

  • Petra Scherenbacher, PhD · Orthomol pharmazeutische Vertriebs GmbH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-08-13
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07779265 on ClinicalTrials.gov