Effect of Bifidobacterium Animalis Subsp. Lactis Bi66 Supplementation on Gut Function in Healthy Adults

NCT ID: NCT06740500

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-10
• Study Completion Date: 2026-03-10

Brief Summary

The goal of this clinical trial is to learn the effect of Bifidobacterium animalis subsp. lactis Bi66 supplementation on gut function in healthy adults. The main questions it aims to answer are:

1. Does Bi66 affect the gut function(bowel movement frequency and stool form)?

2. Does Bi66 affect the gut microbiota and short-chain fatty acids ? Researchers will compare probiotic Bi66 to a placebo (a look-alike substance that contains no Bi66) to see if Bi66 works to affect gut function.

Participants will

1. Take Bi66 or a placebo every day for 8 months

2. Return the used sachets and stool diaries every 7 days and record bowel movement frequency per week and Bristol Stool Scale

3. Have checkups, including questionnaire survey, physical measurement, dietary survey, collection and detection of biological samples at baseline, week 4, week 8

Conditions

Healthy Adult

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Probiotic Bi66

Bi66 group adminster a sachet of probiotic powder (1 g), including Bifidobacterium animalis subsp. lactis Bi66 6.0 × 1010 CFU and a maltodextrin carrier once daily for 8 weeks.

Group Type: EXPERIMENTAL

Probiotic

Intervention Type: DIETARY_SUPPLEMENT

probiotic sachet mainly contains Bifidobacterium animalis subsp. lactis Bi66 and maltodextrin.

Placebo

Placebo group adminster a sachet of placebo powder (1 g) containing maltodextrin once daily for 8 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Maltodextrin

Interventions

Probiotic

probiotic sachet mainly contains Bifidobacterium animalis subsp. lactis Bi66 and maltodextrin.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Maltodextrin

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Bifidobacterium animalis subsp. lactis Bi66

Eligibility Criteria

Inclusion Criteria

• 18-65 years old;
• Self-reported bowel movement frequency less than 5 times per week;
• Change of weight no more than 3 kg within the last 2 months；
• No consumption of probiotics, prebiotics, synbiotics within the last 2 months

Exclusion Criteria

• Pregnant or breastfeeding women；
• Smoking；
• BMI < 18 kg/m2 or ≥28 kg/m2；
• Suffering from gastrointestinal disorders such as gastroenteritis, gastroduodenal ulcer, ulcerative colitis, Crohn's disease, intestinal stress syndrome, functional diarrhea, gastroparesis, etc；
• History of gastrointestinal surgery (except appendectomy or hernia repair)；
• Change in dietary habits within the last 1 month (e.g. ketogenic diet, etc.)；
• History of major surgery within the last 3 months or major surgery planned in the next 1 month;
• Use of antibiotics, acid-suppressing drugs, pro-digestive drugs (gastrointestinal, morpholine, cisapride, etc.), anti-constipation drugs, anti- diarrhea drugs, etc., in the last 1 month;
• Participate in a similar intervention study within the last 1 month

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Liegang Liu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liegang Liu, PhD

Role: PRINCIPAL_INVESTIGATOR

School of Public Health, Tongji Medical College, Huazhong University of Science and Technology

Locations

Huazhong University of Science and Technology

Wuhan, Hubei, China

Countries

China

Central Contacts

Liegang Liu, PhD

Role: CONTACT

liuliegang@mails.tjmu.edu.cn

13487080378

Yi Yang, Master

Role: CONTACT

M202475896@hust.edu.cn

Facility Contacts

Yi Yang, Master

Role: primary

M202475896@hust.edu.cn

18993671732

Other Identifiers

YY202411

Identifier Type: -

Identifier Source: org_study_id