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

NCT06740500 | Completed DMC

• 1 other identifier: YY202411
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

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. 1.Does Bi66 affect the gut function(bowel movement frequency and stool form)?
2. 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.
3. 3.Take Bi66 or a placebo every day for 8 months
4. 4.Return the used sachets and stool diaries every 7 days and record bowel movement frequency per week and Bristol Stool Scale
5. 5.Have checkups, including questionnaire survey, physical measurement, dietary survey, collection and detection of biological samples at baseline, week 4, week 8

Conditions

Healthy Adult

Keywords

probiotic; Bifidobacterium animalis subsp. lactis Bi66; bowel movement frequency; gut microbiota

Outcome Measures

Primary Outcomes (2)

• Bowel movement frequency

  Bowel movement frequency per week will be measured by stool diary

  From enrollment to the end of supplementation at 8 weeks

• gut microbiota

  The fecal microbiota will be measured using 16S rRNA gene amplicon sequencing and change in the composition of beneficial bacteria will be measured using Quantitative Real-time polymerase chain reaction.

  Baseline, 4 weeks, 8 weeks

Secondary Outcomes (3)

• Stool form

  From enrollment to the end of supplementation at 8 weeks

• Fecal short-chain fatty acids

  Baseline, 4 weeks, 8 weeks

• Inflammatory cytokine

  Baseline, 4 weeks, 8 weeks

Study Arms (2)

Probiotic Bi66

EXPERIMENTAL

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.

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

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

Also known as: Bifidobacterium animalis subsp. lactis Bi66

Probiotic Bi66

Placebo DIETARY_SUPPLEMENT

Maltodextrin

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Liegang Liu, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 15, 2024
• First Posted: December 18, 2024
• Study Start: October 17, 2025
• Primary Completion: December 30, 2025
• Study Completion: January 15, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)