Probiotics Improve Health Young Volunteers' Gut Microbiota

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gastrointestinal Diseases Digestive System Diseases

Age range

19 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kang Zou

Nanjing, None Selected, 210095, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Aged 19-45 years;
Willing to voluntarily agree to and comply with the trial protocol, and capable of timely participation in screening and follow-up;
Have not suffered from gastrointestinal diseases in the past month;
Have not taken antibiotics in the past month.

Exclusion criteria

Individuals under 19 or over 45 years of age, with an allergic constitution or allergy to any component of the test substance, symptoms of alcohol allergy, and pregnant or breastfeeding women;
Those who experience discomfort such as diarrhea or bloating after taking the test substance;
Patients with serious diseases of the cardiovascular, liver, kidney, hematopoietic systems, autoimmune diseases, endocrine disorders, mental illnesses, existing high blood sugar, or unhealthy gastrointestinal conditions;
Those who discontinue the test sample or take other medications midway, making it difficult to judge efficacy or with incomplete data;
Recently taken probiotics, prebiotics, or antibiotics related to the function of the test substance, affecting the judgment of results;
Individuals with a daily diet that is either too light or too greasy; those with special dietary structures due to weight loss or other reasons (such as a ketogenic diet);
Individuals with low body fat, BMI < 23.

Treatment and study plan

Probiotic BBr60

Dietary Supplement

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

Placebo

Dietary Supplement

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

Primary outcomes

Changes in intestinal flora

Time frame: 8 weeks

Collect patient fecal samples, test for 16S rRNA

Sponsors and collaborators

Lead sponsor

Wecare Probiotics Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Double-blind Controlled Trial to Assess the Impact of Probiotic on the Intestinal Health of Individuals

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Jan 9, 2024
Registry last updated: Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed