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Probiotics Improve Health Young Volunteers' Gut Microbiota

NCT06196892 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2025-06-13

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate whether daily supplementation with the probiotic Bifidobacterium breve BBr60 can improve metabolic, gastrointestinal, and emotional health in healthy adult volunteers aged 19 to 45 years.

The main questions it aims to answer are: Can B. breve BBr60 improve lipid metabolism (e.g., increase HDL and reduce total cholesterol) in healthy adults? Can B. breve BBr60 alleviate gastrointestinal symptoms and improve emotional well-being in a non-clinical population? Researchers will compare a BBr60 supplementation group to a placebo group to see if the probiotic group experiences greater improvements in metabolic, gastrointestinal, and psychological indicators.

Participants will: Take one sachet daily of either B. breve BBr60 (10 billion CFU) or placebo for 8 weeks. Provide blood and stool samples at baseline and week 8. Complete validated questionnaires assessing alcohol dependence, gastrointestinal symptoms, and emotional status.

Conditions

  • Gastrointestinal Diseases

Interventions

DIETARY_SUPPLEMENT

Probiotic BBr60

Collect patient fecal samples, test for 16S rRNA, and analyze the changes in the patient's gut microbiota before and after taking BBr60.

DIETARY_SUPPLEMENT

Placebo

Collect patient fecal samples, test for 16S rRNA, and analyze the changes in the patient's gut microbiota before and after taking maltodextrin.

Sponsors & Collaborators

  • Wecare Probiotics Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-20
Primary Completion
2024-07-25
Completion
2024-07-26

Countries

  • China

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 NCT06196892 on ClinicalTrials.gov