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

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

Study Overview

• Status: Completed
• Conditions: Healthy Adult
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Probiotic

• Study Type: Interventional
• Enrollment (Actual): 117
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: Probiotic; probiotic sachet mainly contains Bifidobacterium animalis subsp. lactis Bi66 and maltodextrin.; Other Names: Bifidobacterium animalis subsp. lactis Bi66
Placebo Comparator: Placebo; Placebo group adminster a sachet of placebo powder (1 g) containing maltodextrin once daily for 8 weeks.	Dietary supplement: Placebo; Maltodextrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stool form	stool form will be measured by the Bristol Stool Scale (BSS)	From enrollment to the end of supplementation at 8 weeks
Fecal short-chain fatty acids	Fecal short-chain fatty acids will be measured by gas chromatography-mass spectrometry (GC-MS)	Baseline, 4 weeks, 8 weeks
Inflammatory cytokine	Fasting plasma inflammatory cytokine, including CRP, IL-1β, IL-6, IL-8, IL-10, TNF-α, and IFN-γ will be measured by enzyme-linked immunosorbent assay (ELISA)	Baseline, 4 weeks, 8 weeks

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology
• Investigators: Principal Investigator: Liegang Liu, PhD, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2025
• Primary Completion (Actual): December 30, 2025
• Study Completion (Actual): January 15, 2026

Study Registration Dates

• First Submitted: December 15, 2024
• First Submitted That Met QC Criteria: December 15, 2024
• First Posted (Actual): December 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: probiotic; gut microbiota; Bifidobacterium animalis subsp. lactis Bi66; bowel movement frequency
• Additional Relevant MeSH Terms: Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Probiotics
• Other Study ID Numbers: YY202411

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No