Skip to main content
OpenTrials
Completed

NCT Number: NCT06077383

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Qilu hospital

Jinan, Shandong, 250012, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • 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.

Treatment and study plan

Weizmania Coagulans BC99

Dietary Supplement

Probiotics group subjects take probiotics every day for 8 weeks.

Other names: placebo

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: 0, 4 and 8 week

    Verification of the effects of Weizmania Coagulans BC99 on the fat related biomarkers (TG, TC, HDL, LDL) in overweight adult subjects.

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Registry information

Official study title

Effect of Weizmania Coagulans BC99 Intervention on Gut Microbiota and Metabolic Markers in Overweight/Obese Adults: Randomized, Double-blind, Placebo-controlled Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 11, 2023
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.