Gut FunctionNCT05155449
Probiotic Intervention for Gut Function
A study testing Probiotics in people with Gut Function, run by Probi AB at 1 site in China.
Trial summary
The effect of probiotics on gut function in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gut Function
- What is being tested?
- Probiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 8 Feb 2023to 3 Jun 2024
- 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
- Age between 18 and 65 years
- BMI between 18.5 and 27.9 kg/m²
- Subjects having ≥ 3 bowel movements per day
- Subject not satisfied with their bowel habits
- Subject having frequent stools during more than 4 weeks
- For women: Non menopausal with the same reliable contraception since at least 3 cycles before the beginning of the study and agreeing to keep it during the entire duration of the study
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- Subjects agreeing to keep their dietary and life habits unchanged throughout the study
- Good general and mental health within the opinion of the investigator
- Able and willing to participate to the study by complying with the protocol procedures as evidenced by a dated and signed ICF
Who cannot join
- Suffering IBS according to Rome IV criteria, chronic intestinal disease, immunodeficiency disorder or immunosuppressive treatment
- Clinically significant frequent constipation or diarrhea at the screening visit as judged by the Investigator
- Suffering from a severe chronic disease or GI disorders found to be inconsistent with the conduct of the study by the investigator
- Intake of antibiotics within 8 weeks prior to the start of the study
- With regular intake of probiotics within four weeks prior to V1 visit
- Under treatment or dietary supplement which could significantly affect parameter(s) followed during the study according to the investigator or stopped in a too short period before the V1 visit
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- Suspected alcohol or substance abuse
- Use of medications other than contraceptives or prescribed medication after consulting with the investigator
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk if participating in the study, or influence the results or the subject´s ability to participate in the study
- With a known gluten intolerance, milk protein allergy
- With a known or suspected food allergy or intolerance or hypersensitivity to any of the study products' ingredients
- Pregnant or lactating women or intending to become pregnant within 3 months ahead
- With significant change in food habits or in physical activity in the 3 months before the V1 visit
- With a personal history of anorexia nervosa, bulimia or significant eating disorders according to the investigator
- Having a lifestyle deemed incompatible with the study according to the investigator
- Currently participating in another clinical study, has done so in the past 30 days or being in the exclusion period of a previous clinical trial
- Under legal protection (guardianship, wardship) or deprived from his/her rights following administrative or judicial decision
- Presenting a psychological or linguistic incapability to sign the informed consent or Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements
- Impossible to contact in case of emergency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Effect of Probiotics on Gut Function in Healthy Chinese Adults
The effect of probiotics on gut function in healthy subjects.
- Conditions
- Gut Function
- Being tested
- Probiotics, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsDietary supplement
Capsule
PlaceboDietary supplement
Capsule
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Active comparator | Two capsules per day for 8 weeks Receives: Dietary Supplement: Probiotics |
| Placebo | Placebo comparator | Two capsules per day 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 movements
Reduction of the number of bowel movements
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start8 Feb 2023
- Primary completion3 Jun 2024
- Study completion3 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut FunctionStudies of the same condition, open and under way.
- 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Probi AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiangjun Meng, MD, Principal investigator, Shanghai 9th People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05155449
- Sponsor's protocol ID
- PEC19132
- Status last verified
- Jun 2025
- First submitted
- 30 Nov 2021
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Effect of Probiotics on Gut Function in Healthy Chinese Adults
- ClinicalTrials.gov ID
- NCT05155449
- Acronym / sponsor ID
- PEC19132
- Conditions
- Gut Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Probi ABIndustry (pharma, biotech, devices)
- Study start
- 8 Feb 2023 (actual)
- Primary completion
- 3 Jun 2024 (actual)
- Study completion
- 3 Jun 2024 (actual)
- First posted
- 13 Dec 2021 (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 effect of probiotics on gut function in healthy subjects.
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 |
|---|---|---|
| Probiotics | Active comparator | Dietary Supplement: ProbioticsTwo capsules per day for 8 weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboTwo capsules per day for 8 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age between 18 and 65 years
- BMI between 18.5 and 27.9 kg/m²
- Subjects having ≥ 3 bowel movements per day
- Subject not satisfied with their bowel habits
- Subject having frequent stools during more than 4 weeks
Key exclusion criteria (19 listed)
- Suffering IBS according to Rome IV criteria, chronic intestinal disease, immunodeficiency disorder or immunosuppressive treatment
- Clinically significant frequent constipation or diarrhea at the screening visit as judged by the Investigator
- Suffering from a severe chronic disease or GI disorders found to be inconsistent with the conduct of the study by the investigator
- Intake of antibiotics within 8 weeks prior to the start of the study
- With regular intake of probiotics within four weeks prior to V1 visit
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 |
|---|---|---|
| ProbioticsCapsule | Dietary supplement | Probiotics |
| PlaceboCapsule | Dietary supplement | Placebo |
Primary outcome
Bowel movements
Time frame: 8 weeks
Reduction of the number of bowel movements
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 18 Jun 2025.
- 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.
Xiangjun Meng, MD principal investigator
Shanghai 9th People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics in people with Gut Function, run by Probi AB 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 9 inclusion and 19 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 18 Jun 2025. 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 movements (time frame: 8 weeks). 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 18 Jun 2025; AzTrials last refreshed its copy on 27 Oct 2026.