Effect of Weizmania Coagulans BC99 Intervention on Gut Microbiota and Metabolic Markers in Overweight/Obese Adults

NCT ID: NCT06077383

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-25
• Study Completion Date: 2024-07-30

Brief 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. 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.

Conditions

Overweight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Probiotics group

Probiotics group subjects take probiotics every day for 8 weeks.

Group Type: EXPERIMENTAL

Weizmania Coagulans BC99

Intervention Type: DIETARY_SUPPLEMENT

Probiotics group subjects take probiotics every day for 8 weeks.

Placebo group

Placebo group subjects take placebo every day for 8 weeks.

Group Type: PLACEBO_COMPARATOR

Weizmania Coagulans BC99

Intervention Type: DIETARY_SUPPLEMENT

Probiotics group subjects take probiotics every day for 8 weeks.

Interventions

Weizmania Coagulans BC99

Probiotics group subjects take probiotics every day for 8 weeks.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

placebo

Eligibility Criteria

Inclusion Criteria

1. All patients meet the diagnostic criteria for severe illness, and a body mass index (BMI) of ≥ 24kg/m2 is considered overweight;

2. Age 18-65 years old;

3. Without dieting or weight loss, and able to accept dietary intervention, maintain a low-carbon and healthy diet during the trial period;

4. Patients who understand clinical research and commit to complying with research requirements and procedures;

5. Patients who have signed informed consent forms. Able to complete research according to the requirements of the experimental protocol;

Exclusion Criteria

1. Taking items with similar functions to the test subjects in the short term can affect the judgment of the results;

2. Have taken antibiotics 2 weeks before recruitment;

3. Those who stop taking the test sample or add other drugs midway, and cannot determine the efficacy or have incomplete information;

4. Obesity caused by drug treatment (hormones, antidepressants, etc.), endocrine diseases, combined with severe liver and kidney dysfunction, water retention or muscle development;

5. Patients who are pregnant, lactating, stomatal, critically ill, or have potential health conditions that affect metabolism or weight;

6. Neuroendocrine system diseases (hypothyroidism, polycystic ovary syndrome, Cushing's syndrome, hypothalamic injury, etc.);

7. 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);

8. 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.);

9. Patients who changed their diet type during the study period;

10. Patients with severe diseases such as cardiovascular, cerebrovascular, liver, kidney, and hematopoietic systems, as well as endocrine diseases, and mental illnesses;

11. According to the researcher's judgment, the condition of the subject does not qualify them to participate in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Hospital of Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Qilu hospital

Jinan, Shandong, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 40416368 (View on PubMed)

Other Identifiers

QLYY-202307-008

Identifier Type: -

Identifier Source: org_study_id