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

September 30, 2025 updated by: Qilu Hospital of Shandong University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Qilu hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Probiotics group
Probiotics group subjects take probiotics every day for 8 weeks.
Dietary supplement: Weizmania Coagulans BC99
Probiotics group subjects take probiotics every day for 8 weeks.
Other Names:
  • placebo
Placebo Comparator: Placebo group
Placebo group subjects take placebo every day for 8 weeks.
Dietary supplement: Weizmania Coagulans BC99
Probiotics group subjects take probiotics every day for 8 weeks.
Other Names:
  • placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
0, 4 and 8 week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
0, 4 and 8 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Qilu Hospital of Shandong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 25, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 8, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 11, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 6, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • QLYY-202307-008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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