Probiotics Improve Health Young Volunteers' Gut Microbiota

NCT06196892 | Completed

• 1 other identifier: WK2023007
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Changes in intestinal flora

  Collect patient fecal samples, test for 16S rRNA

  8 weeks

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

one sachet per day, with maltodextrin

Dietary Supplement: Placebo

Probiotic group

EXPERIMENTAL

one sachet per day, with BBr60 and maltodextrin

Dietary Supplement: Probiotic BBr60

Interventions

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.

Probiotic group

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.

Placebo group

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wecare Probiotics Co., Ltd.: lead

Study Sites (1)

Kang Zou

Nanjing, None Selected, 210095, China

Location

Related Publications (1)

• 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.

  PMID: 40652782 DERIVED

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2023
• First Posted: January 9, 2024
• Study Start: April 20, 2024
• Primary Completion: July 25, 2024
• Study Completion: July 26, 2024
• Last Updated: June 13, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)