Effect of Bifidobacterium Animalis Subsp. Lactis Bi66 Supplementation on Gut Function in Healthy Adults
NCT06740500 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 117
Last updated 2026-03-30
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
Interventions
- DIETARY_SUPPLEMENT
-
Probiotic
probiotic sachet mainly contains Bifidobacterium animalis subsp. lactis Bi66 and maltodextrin.
- DIETARY_SUPPLEMENT
-
Placebo
Maltodextrin
Sponsors & Collaborators
-
Huazhong University of Science and Technology
lead OTHER
Principal Investigators
-
Liegang Liu, PhD · School of Public Health, Tongji Medical College, Huazhong University of Science and Technology
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-10-17
- Primary Completion
- 2025-12-30
- Completion
- 2026-01-15
Countries
- China
Study Locations
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