NCT06740500

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

Effect of Bifidobacterium Animalis Subsp. Lactis Bi66 Supplementation on Gut Function in Healthy Adults: a Double-blind Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic	probiotic sachet mainly contains Bifidobacterium animalis subsp. lactis Bi66 and maltodextrin.
DIETARY_SUPPLEMENT	Placebo	Maltodextrin

Timeline

• Start date: 2025-10-17
• Primary completion: 2025-12-30
• Completion: 2026-01-15
• First posted: 2024-12-18
• Last updated: 2026-03-30

Locations

1 site across 1 country: China