Healthy AdultNCT06740500
Effect of Bifidobacterium Animalis Subsp. Lactis Bi66 Supplementation on Gut Function in Healthy Adults
A study testing Probiotic in people with Healthy Adult, run by Huazhong University of Science and Technology at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 117 participants
- Where
- 1 siteChina
- Study dates
- 17 Oct 2025to 15 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.)；
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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:
- Does Bi66 affect the gut function(bowel movement frequency and stool form)?
- 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.
Read more
Participants will
- Take Bi66 or a placebo every day for 8 months
- Return the used sachets and stool diaries every 7 days and record bowel movement frequency per week and Bristol Stool Scale
- Have checkups, including questionnaire survey, physical measurement, dietary survey, collection and detection of biological samples at baseline, week 4, week 8
- Conditions
- Healthy Adult
- Being tested
- Probiotic, Placebo
- Keywords
- probiotic, Bifidobacterium animalis subsp. lactis Bi66, bowel movement frequency, gut microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Also called Bifidobacterium animalis subsp. lactis Bi66
probiotic sachet mainly contains Bifidobacterium animalis subsp. lactis Bi66 and maltodextrin.
PlaceboDietary supplement
Maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | Placebo group adminster a sachet of placebo powder (1 g) containing maltodextrin once daily for 8 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel movement frequency
Bowel movement frequency per week will be measured by stool diary
Measured: 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.
Measured: Baseline, 4 weeks, 8 weeks
Secondary outcomes (3)
Stool form
stool form will be measured by the Bristol Stool Scale (BSS)
Measured: 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)
Measured: 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)
Measured: Baseline, 4 weeks, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start17 Oct 2025
- Primary completion30 Dec 2025
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liegang Liu, Huazhong University of Science and Technology
- Investigators
- Liegang Liu, PhD, Principal investigator, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06740500
- Sponsor's protocol ID
- YY202411
- Status last verified
- Mar 2026
- First submitted
- 15 Dec 2024
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bifidobacterium Animalis Subsp. Lactis Bi66 Supplementation on Gut Function in Healthy Adults: a Double-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06740500
- Acronym / sponsor ID
- YY202411
- Conditions
- Healthy Adult
- Keywords
- probiotic, Bifidobacterium animalis subsp. lactis Bi66, bowel movement frequency, gut microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 17 Oct 2025 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does Bi66 affect the gut function(bowel movement frequency and stool form)?
- 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
- Take Bi66 or a placebo every day for 8 months
- Return the used sachets and stool diaries every 7 days and record bowel movement frequency per week and Bristol Stool Scale
- Have checkups, including questionnaire survey, physical measurement, dietary survey, collection and detection of biological samples at baseline, week 4, week 8
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic Bi66 | Experimental | Dietary Supplement: ProbioticBi66 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. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo group adminster a sachet of placebo powder (1 g) containing maltodextrin once daily for 8 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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)；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticAlso: Bifidobacterium animalis subsp. lactis Bi66probiotic sachet mainly contains Bifidobacterium animalis subsp. lactis Bi66 and maltodextrin. | Dietary supplement | Probiotic Bi66 |
| PlaceboMaltodextrin | Dietary supplement | Placebo |
Primary outcome
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
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.
3 secondary outcomes
Stool form
Time frame: From enrollment to the end of supplementation at 8 weeks
Fecal short-chain fatty acids
Time frame: Baseline, 4 weeks, 8 weeks
Inflammatory cytokine
Time frame: Baseline, 4 weeks, 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liegang Liu, PhD principal investigator
School of Public Health, Tongji Medical College, Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Healthy Adult, run by Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bowel movement frequency (time frame: From enrollment to the end of supplementation at 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.