Probiotics Improve Health Young Volunteers' Gut Microbiota

NCT ID: NCT06196892

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 109 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-20
• Study Completion Date: 2024-07-26

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo group

one sachet per day, with maltodextrin

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Probiotic group

one sachet per day, with BBr60 and maltodextrin

Group Type: EXPERIMENTAL

Probiotic BBr60

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. Aged 19-45 years;

2. Willing to voluntarily agree to and comply with the trial protocol, and capable of timely participation in screening and follow-up;

3. Have not suffered from gastrointestinal diseases in the past month;

4. Have not taken antibiotics in the past month.

Exclusion Criteria

1. 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;

2. Those who experience discomfort such as diarrhea or bloating after taking the test substance;

3. 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;

4. Those who discontinue the test sample or take other medications midway, making it difficult to judge efficacy or with incomplete data;

5. Recently taken probiotics, prebiotics, or antibiotics related to the function of the test substance, affecting the judgment of results;

6. 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);

7. Individuals with low body fat, BMI < 23.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wecare Probiotics Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kang Zou

Nanjing, None Selected, China

Countries

China

References

Dong Y, Cai Y, Tian H, Wen J, Han M, Tan Y, Zou K. The impact of Bifidobacterium breve BBr60 (BBr60) on metabolic and gastrointestinal health in healthy adults: A combined in vitro metabolomic and randomized, double-blind, placebo-controlled study. Clin Nutr. 2025 Aug;51:349-361. doi: 10.1016/j.clnu.2025.07.004. Epub 2025 Jul 7.

Reference Type: DERIVED

PMID: 40652782 (View on PubMed)

Other Identifiers

WK2023007

Identifier Type: -

Identifier Source: org_study_id