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

Primary Purpose

Overweight

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Weizmania Coagulans BC99
Sponsored by
Qilu Hospital of Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Probiotics group

    Placebo group

    Arm Description

    Probiotics group subjects take probiotics every day for 8 weeks.

    Placebo group subjects take placebo every day for 8 weeks.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    September 8, 2023
    Last Updated
    October 8, 2023
    Sponsor
    Qilu Hospital of Shandong University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06077383
    Brief Title
    Effect of Weizmania Coagulans BC99 Intervention on Gut Microbiota and Metabolic Markers in Overweight Adults
    Official Title
    Effect of Weizmania Coagulans BC99 Intervention on Gut Microbiota and Metabolic Markers in Overweight Adults: Randomized, Double-blind, Placebo-controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 10, 2023 (Anticipated)
    Primary Completion Date
    July 30, 2024 (Anticipated)
    Study Completion Date
    August 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Qilu Hospital of Shandong University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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 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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Overweight

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Masking Description
    double blind
    Allocation
    Randomized
    Enrollment
    72 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Probiotics group
    Arm Type
    Experimental
    Arm Description
    Probiotics group subjects take probiotics every day for 8 weeks.
    Arm Title
    Placebo group
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo group subjects take placebo every day for 8 weeks.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Weizmania Coagulans BC99
    Other Intervention Name(s)
    placebo
    Intervention Description
    Probiotics group subjects take probiotics every day for 8 weeks.
    Primary Outcome Measure Information:
    Title
    The gut microbiota were sequenced by 16s high-throughput sequencing.
    Description
    Verification of the effects of Weizmania Coagulans BC99 on the gut microbiota in overweight adult subjects.
    Time Frame
    0, 4 and 8 week
    Secondary Outcome Measure Information:
    Title
    The fat related biomarkers (TG, TC, HDL, LDL) were detected by blood biochemistry.
    Description
    Verification of the effects of Weizmania Coagulans BC99 on the fat related biomarkers (TG, TC, HDL, LDL) in overweight adult subjects.
    Time Frame
    0, 4 and 8 week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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