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

NCT06077383 | Completed DMC

• 1 other identifier: QLYY-202307-008
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight

Outcome Measures

Primary Outcomes (1)

• 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.

  0, 4 and 8 week

Secondary Outcomes (1)

• The fat related biomarkers (TG, TC, HDL, LDL) were detected by blood biochemistry.

  0, 4 and 8 week

Study Arms (2)

Probiotics group

EXPERIMENTAL

Probiotics group subjects take probiotics every day for 8 weeks.

Dietary Supplement: Weizmania Coagulans BC99

Placebo group

PLACEBO COMPARATOR

Placebo group subjects take placebo every day for 8 weeks.

Dietary Supplement: Weizmania Coagulans BC99

Interventions

Weizmania Coagulans BC99 DIETARY_SUPPLEMENT

Probiotics group subjects take probiotics every day for 8 weeks.

Also known as: placebo

Placebo group; Probiotics group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.);
• 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu hospital

Jinan, Shandong, 250012, China

Location

Related Publications (1)

• 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.

  PMID: 40416368 DERIVED

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: October 11, 2023
• Study Start: October 25, 2023
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: October 6, 2025

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)