Gastrointestinal DiseasesNCT06196892
Probiotics Improve Health Young Volunteers' Gut Microbiota
A study testing Probiotic BBr60 in people with Gastrointestinal Diseases, run by Wecare Probiotics Co., Ltd. at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate whether daily supplementation with the probiotic Bifidobacterium breve BBr60 can improve metabolic, gastrointestinal, and emotional health in healthy adult volunteers aged 19 to 45 years. The main questions it aims to answer are: Can B. Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Diseases
- What is being tested?
- Probiotic BBr60
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2024to 26 Jul 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 19 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 19-45 years;
- Willing to voluntarily agree to and comply with the trial protocol, and capable of timely participation in screening and follow-up;
- Have not suffered from gastrointestinal diseases in the past month;
- Have not taken antibiotics in the past month.
Who cannot join
- Individuals under 19 or over 45 years of age, with an allergic constitution or allergy to any component of the test substance, symptoms of alcohol allergy, and pregnant or breastfeeding women;
- Those who experience discomfort such as diarrhea or bloating after taking the test substance;
- Patients with serious diseases of the cardiovascular, liver, kidney, hematopoietic systems, autoimmune diseases, endocrine disorders, mental illnesses, existing high blood sugar, or unhealthy gastrointestinal conditions;
- Those who discontinue the test sample or take other medications midway, making it difficult to judge efficacy or with incomplete data;
- Recently taken probiotics, prebiotics, or antibiotics related to the function of the test substance, affecting the judgment of results;
- Individuals with a daily diet that is either too light or too greasy; those with special dietary structures due to weight loss or other reasons (such as a ketogenic diet);
- Individuals with low body fat, BMI < 23.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind Controlled Trial to Assess the Impact of Probiotic on the Intestinal Health of Individuals
The goal of this clinical trial is to evaluate whether daily supplementation with the probiotic Bifidobacterium breve BBr60 can improve metabolic, gastrointestinal, and emotional health in healthy adult volunteers aged 19 to 45 years.
The main questions it aims to answer are: Can B. breve BBr60 improve lipid metabolism (e.g., increase HDL and reduce total cholesterol) in healthy adults? Can B. breve BBr60 alleviate gastrointestinal symptoms and improve emotional well-being in a non-clinical population? Researchers will compare a BBr60 supplementation group to a placebo group to see if the probiotic group experiences greater improvements in metabolic, gastrointestinal, and psychological indicators.
Participants will: Take one sachet daily of either B. breve BBr60 (10 billion CFU) or placebo for 8 weeks. Provide blood and stool samples at baseline and week 8. Complete validated questionnaires assessing alcohol dependence, gastrointestinal symptoms, and emotional status.
- Conditions
- Gastrointestinal Diseases
- Being tested
- Probiotic BBr60, Placebo
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic BBr60Dietary supplement
Collect patient fecal samples, test for 16S rRNA, and analyze the changes in the patient's gut microbiota before and after taking BBr60.
PlaceboDietary supplement
Collect patient fecal samples, test for 16S rRNA, and analyze the changes in the patient's gut microbiota before and after taking maltodextrin.
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | one sachet per day, with maltodextrin Receives: Dietary Supplement: Placebo |
| Probiotic group | Experimental | one sachet per day, with BBr60 and maltodextrin Receives: Dietary Supplement: Probiotic BBr60 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in intestinal flora
Collect patient fecal samples, test for 16S rRNA
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 posted9 Jan 2024
- Study start20 Apr 2024
- Primary completion25 Jul 2024
- Study completion26 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal DiseasesStudies of the same condition, open and under way.
- More trials run by Wecare Probiotics Co., Ltd.The 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wecare Probiotics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06196892
- Sponsor's protocol ID
- WK2023007
- Status last verified
- Jul 2024
- First submitted
- 24 Dec 2023
- Last updated
- 13 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dong Y, Cai Y, Tian H, Wen J, Han M, Tan Y, Zou K. The impact of Bifidobacterium breve BBr60 (BBr60) on metabolic and gastrointestinal health in healthy adults: A combined in vitro metabolomic and randomized, double-blind, placebo-controlled study. Clin Nutr. 2025 Aug;51:349-361. doi: 10.1016/j.clnu.2025.07.004. Epub 2025 Jul 7.
PubMed 40652782
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Controlled Trial to Assess the Impact of Probiotic on the Intestinal Health of Individuals
- ClinicalTrials.gov ID
- NCT06196892
- Acronym / sponsor ID
- WK2023007
- Conditions
- Gastrointestinal Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Wecare Probiotics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Apr 2024 (actual)
- Primary completion
- 25 Jul 2024 (actual)
- Study completion
- 26 Jul 2024 (actual)
- First posted
- 9 Jan 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 evaluate whether daily supplementation with the probiotic Bifidobacterium breve BBr60 can improve metabolic, gastrointestinal, and emotional health in healthy adult volunteers aged 19 to 45 years.
The main questions it aims to answer are: Can B. breve BBr60 improve lipid metabolism (e.g., increase HDL and reduce total cholesterol) in healthy adults? Can B. breve BBr60 alleviate gastrointestinal symptoms and improve emotional well-being in a non-clinical population? Researchers will compare a BBr60 supplementation group to a placebo group to see if the probiotic group experiences greater improvements in metabolic, gastrointestinal, and psychological indicators.
Participants will: Take one sachet daily of either B. breve BBr60 (10 billion CFU) or placebo for 8 weeks. Provide blood and stool samples at baseline and week 8. Complete validated questionnaires assessing alcohol dependence, gastrointestinal symptoms, and emotional status.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Dietary Supplement: Placeboone sachet per day, with maltodextrin |
| Probiotic group | Experimental | Dietary Supplement: Probiotic BBr60one sachet per day, with BBr60 and maltodextrin |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged 19-45 years;
- Willing to voluntarily agree to and comply with the trial protocol, and capable of timely participation in screening and follow-up;
- Have not suffered from gastrointestinal diseases in the past month;
- Have not taken antibiotics in the past month.
Key exclusion criteria (7 listed)
- Individuals under 19 or over 45 years of age, with an allergic constitution or allergy to any component of the test substance, symptoms of alcohol allergy, and pregnant or breastfeeding women;
- Those who experience discomfort such as diarrhea or bloating after taking the test substance;
- Patients with serious diseases of the cardiovascular, liver, kidney, hematopoietic systems, autoimmune diseases, endocrine disorders, mental illnesses, existing high blood sugar, or unhealthy gastrointestinal conditions;
- Those who discontinue the test sample or take other medications midway, making it difficult to judge efficacy or with incomplete data;
- Recently taken probiotics, prebiotics, or antibiotics related to the function of the test substance, affecting the judgment of results;
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 |
|---|---|---|
| Probiotic BBr60Collect patient fecal samples, test for 16S rRNA, and analyze the changes in the patient's gut microbiota before and after taking BBr60. | Dietary supplement | Probiotic group |
| PlaceboCollect patient fecal samples, test for 16S rRNA, and analyze the changes in the patient's gut microbiota before and after taking maltodextrin. | Dietary supplement | Placebo group |
Primary outcome
Changes in intestinal flora
Time frame: 8 weeks
Collect patient fecal samples, test for 16S rRNA
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 13 Jun 2025.
- Derived from this study: PubMed 40652782Dong Y, Cai Y, Tian H, Wen J, Han M, Tan Y, Zou K. The impact of Bifidobacterium breve BBr60 (BBr60) on metabolic and gastrointestinal health in healthy adults: A combined in vitro metabolomic and randomized, double-blind, placebo-controlled study. Clin Nutr. 2025 Aug;51:349-361. doi: 10.1016/j.clnu.2025.07.004. Epub 2025 Jul 7.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 BBr60 in people with Gastrointestinal Diseases, run by Wecare Probiotics Co., Ltd. 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 7 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 13 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?
Changes in intestinal flora (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06196892, which also lists 1 linked publication.
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 13 Jun 2025.