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

Huazhong University of Science and Technology

Status: Not yet enrolling

Conditions: Healthy Adult

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Probiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT06740500

YY202411

Details and patient eligibility

About

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

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

Probiotic Bi66

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Probiotic

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo