OverweightNCT06077383
Effect of Weizmania Coagulans BC99 Intervention on Gut Microbiota and Metabolic Markers in Overweight/Obese Adults
A study testing Weizmania Coagulans BC99 in people with Overweight, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
The main purpose of this study is to verify the effects of Weizmania Coagulans BC99 on the gut microbiota and fat related markers (TG, TC, HDL, LDL) in overweight/Obese adult subjects. The subjects participate were randomly grouped and receive intervention with Weizmann clotting bacteria BC99 or placebo. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Overweight
- What is being tested?
- Weizmania Coagulans BC99
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 25 Oct 2023to 30 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients meet the diagnostic criteria for severe illness, and a body mass index (BMI) of ≥ 24kg/m2 is considered overweight;
- Age 18-65 years old;
- Without dieting or weight loss, and able to accept dietary intervention, maintain a low-carbon and healthy diet during the trial period;
- Patients who understand clinical research and commit to complying with research requirements and procedures;
- Patients who have signed informed consent forms. Able to complete research according to the requirements of the experimental protocol;
Who cannot join
- Taking items with similar functions to the test subjects in the short term can affect the judgment of the results;
- Have taken antibiotics 2 weeks before recruitment;
- Those who stop taking the test sample or add other drugs midway, and cannot determine the efficacy or have incomplete information;
- Obesity caused by drug treatment (hormones, antidepressants, etc.), endocrine diseases, combined with severe liver and kidney dysfunction, water retention or muscle development;
- Patients who are pregnant, lactating, stomatal, critically ill, or have potential health conditions that affect metabolism or weight;
- Neuroendocrine system diseases (hypothyroidism, polycystic ovary syndrome, Cushing's syndrome, hypothalamic injury, etc.);
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- Have a clear history of gastrointestinal diseases (such as ulcers, gastrointestinal bleeding, irritable bowel syndrome, celiac disease, inflammatory bowel disease, Crohn's disease, or other diseases) and a history of surgery (such as weight loss surgery, bandaging surgery, gastrointestinal anastomosis surgery, and intestinal resection surgery);
- Hereditary obesity Hereditary obesity (such as PWS, Down's syndrome), metabolic obesity (such as obesity reproductive impotence syndrome), endocrine obesity (such as Kirschner's syndrome, hypothyroidism), any disease affecting liver fibrosis or steatosis, metabolic disease (such as hypothyroidism/hyperthyroidism, type 1 or type 2 diabetes, etc.);
- Patients who changed their diet type during the study period;
- Patients with severe diseases such as cardiovascular, cerebrovascular, liver, kidney, and hematopoietic systems, as well as endocrine diseases, and mental illnesses;
- According to the researcher's judgment, the condition of the subject does not qualify them to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Weizmania Coagulans BC99 Intervention on Gut Microbiota and Metabolic Markers in Overweight/Obese Adults: Randomized, Double-blind, Placebo-controlled Trial
The main purpose of this study is to verify the effects of Weizmania Coagulans BC99 on the gut microbiota and fat related markers (TG, TC, HDL, LDL) in overweight/Obese adult subjects.
The subjects participate were randomly grouped and receive intervention with Weizmann clotting bacteria BC99 or placebo. The total duration of the study is 8 weeks. After the intervention, blood, urine, and feces samples of the subjects need to be collected and promptly tested in the laboratory. During the intervention period, each group of subjects was required to take the corresponding product daily and record complications.
Read the detailed description
The main purpose of this study is to verify the effects of Weizmania Coagulans BC99 on the gut microbiota and fat related markers (TG, TC, HDL, LDL) in overweight/Obese adult subjects.
The subjects participate in the screening on a voluntary basis, and those who pass the screening will enter the trial. Randomly group and receive intervention with Weizmann clotting bacteria BC99 or placebo. The total duration of the study is 8 weeks, including 1 week before the trial (followed up once), 4 weeks during the trial (followed up once a week), and 8 weeks during the trial (followed up once a week). After the intervention, blood, urine, and feces samples of the subjects need to be collected and promptly tested in the laboratory. During the intervention period, each group of subjects was required to take the corresponding product daily and record complications.
- Conditions
- Overweight
- Being tested
- Weizmania Coagulans BC99
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weizmania Coagulans BC99Dietary supplement
Also called placebo
Probiotics group subjects take probiotics every day for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Probiotics group | Experimental | Probiotics group subjects take probiotics every day for 8 weeks. Receives: Dietary Supplement: Weizmania Coagulans BC99 |
| Placebo group | Placebo comparator | Placebo group subjects take placebo every day for 8 weeks. Receives: Dietary Supplement: Weizmania Coagulans BC99 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The gut microbiota were sequenced by 16s high-throughput sequencing.
Verification of the effects of Weizmania Coagulans BC99 on the gut microbiota in overweight adult subjects.
Measured: 0, 4 and 8 week
Secondary outcomes (1)
The fat related biomarkers (TG, TC, HDL, LDL) were detected by blood biochemistry.
Verification of the effects of Weizmania Coagulans BC99 on the fat related biomarkers (TG, TC, HDL, LDL) in overweight adult subjects.
Measured: 0, 4 and 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start25 Oct 2023
- Primary completion30 Jul 2024
- Study completion30 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 OverweightStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe 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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06077383
- Sponsor's protocol ID
- QLYY-202307-008
- Status last verified
- Sep 2023
- First submitted
- 8 Sep 2023
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang R, Zhang G, Wang X, Xing Z, Li Z, Li L. Effect of Bacillus coagulans BC99 supplementation on body weight and gut microbiota in overweight and obese individual: a randomized, double-blind, placebo-controlled study. Front Nutr. 2025 May 9;12:1542145. doi: 10.3389/fnut.2025.1542145. eCollection 2025.
PubMed 40416368
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Weizmania Coagulans BC99 Intervention on Gut Microbiota and Metabolic Markers in Overweight/Obese Adults: Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT06077383
- Acronym / sponsor ID
- QLYY-202307-008
- Conditions
- Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 11 Oct 2023 (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 main purpose of this study is to verify the effects of Weizmania Coagulans BC99 on the gut microbiota and fat related markers (TG, TC, HDL, LDL) in overweight/Obese adult subjects.
The subjects participate were randomly grouped and receive intervention with Weizmann clotting bacteria BC99 or placebo. The total duration of the study is 8 weeks. After the intervention, blood, urine, and feces samples of the subjects need to be collected and promptly tested in the laboratory. During the intervention period, each group of subjects was required to take the corresponding product daily and record complications.
Detailed description
The main purpose of this study is to verify the effects of Weizmania Coagulans BC99 on the gut microbiota and fat related markers (TG, TC, HDL, LDL) in overweight/Obese adult subjects.
The subjects participate in the screening on a voluntary basis, and those who pass the screening will enter the trial. Randomly group and receive intervention with Weizmann clotting bacteria BC99 or placebo. The total duration of the study is 8 weeks, including 1 week before the trial (followed up once), 4 weeks during the trial (followed up once a week), and 8 weeks during the trial (followed up once a week). After the intervention, blood, urine, and feces samples of the subjects need to be collected and promptly tested in the laboratory. During the intervention period, each group of subjects was required to take the corresponding product daily and record complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics group | Experimental | Dietary Supplement: Weizmania Coagulans BC99Probiotics group subjects take probiotics every day for 8 weeks. |
| Placebo group | Placebo comparator | Dietary Supplement: Weizmania Coagulans BC99Placebo group subjects take placebo every day for 8 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All patients meet the diagnostic criteria for severe illness, and a body mass index (BMI) of ≥ 24kg/m2 is considered overweight;
- Age 18-65 years old;
- Without dieting or weight loss, and able to accept dietary intervention, maintain a low-carbon and healthy diet during the trial period;
- Patients who understand clinical research and commit to complying with research requirements and procedures;
- Patients who have signed informed consent forms. Able to complete research according to the requirements of the experimental protocol;
Key exclusion criteria (11 listed)
- Taking items with similar functions to the test subjects in the short term can affect the judgment of the results;
- Have taken antibiotics 2 weeks before recruitment;
- Those who stop taking the test sample or add other drugs midway, and cannot determine the efficacy or have incomplete information;
- Obesity caused by drug treatment (hormones, antidepressants, etc.), endocrine diseases, combined with severe liver and kidney dysfunction, water retention or muscle development;
- Patients who are pregnant, lactating, stomatal, critically ill, or have potential health conditions that affect metabolism or weight;
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 |
|---|---|---|
| Weizmania Coagulans BC99Also: placeboProbiotics group subjects take probiotics every day for 8 weeks. | Dietary supplement | Placebo group, Probiotics group |
Primary outcome
The gut microbiota were sequenced by 16s high-throughput sequencing.
Time frame: 0, 4 and 8 week
Verification of the effects of Weizmania Coagulans BC99 on the gut microbiota in overweight adult subjects.
1 secondary outcome
The fat related biomarkers (TG, TC, HDL, LDL) were detected by blood biochemistry.
Time frame: 0, 4 and 8 week
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 6 Oct 2025.
- Derived from this study: PubMed 40416368Wang R, Zhang G, Wang X, Xing Z, Li Z, Li L. Effect of Bacillus coagulans BC99 supplementation on body weight and gut microbiota in overweight and obese individual: a randomized, double-blind, placebo-controlled study. Front Nutr. 2025 May 9;12:1542145. doi: 10.3389/fnut.2025.1542145. eCollection 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.
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 Weizmania Coagulans BC99 in people with Overweight, run by Qilu Hospital of Shandong University 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 5 inclusion and 11 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 6 Oct 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?
The gut microbiota were sequenced by 16s high-throughput sequencing. (time frame: 0, 4 and 8 week). 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 NCT06077383, 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 6 Oct 2025.