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Completed

NCT Number: NCT06740500

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

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

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Key information

Conditions

Healthy Adult

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic

Dietary Supplement

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

Other names: Bifidobacterium animalis subsp. lactis Bi66

Placebo

Dietary Supplement

Maltodextrin

Primary outcomes

  1. Bowel movement frequency

    Time frame: From enrollment to the end of supplementation at 8 weeks

    Bowel movement frequency per week will be measured by stool diary

  2. gut microbiota

    Time frame: Baseline, 4 weeks, 8 weeks

    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.

Secondary outcomes

  1. Stool form

    Time frame: From enrollment to the end of supplementation at 8 weeks

    stool form will be measured by the Bristol Stool Scale (BSS)

  2. Fecal short-chain fatty acids

    Time frame: Baseline, 4 weeks, 8 weeks

    Fecal short-chain fatty acids will be measured by gas chromatography-mass spectrometry (GC-MS)

  3. Inflammatory cytokine

    Time frame: Baseline, 4 weeks, 8 weeks

    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)

Sponsors and collaborators

Lead sponsor

Huazhong University of Science and Technology

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Dec 18, 2024
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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