Obesity and Metabolic Syndrome
Conditions
Interventions
Fecal microbiota transplantation (FMT) placebo group:Take 4 placebo capsules orally twice daily (b.i.d.) for 6 consecutive days per treatment course. Maintain a 3-week washout period between courses,
Fecal microbiota transplantation (FMT) treatment group:Take 4 capsules of human-derived active intestinal microbiota orally, twice daily (b.i.d.). Each treatment course comprises 6 consecutive days, f
Sponsors
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: (1) Age: 18–60 years, (2) Obesity status: Moderate obesity or higher Body Mass Index (BMI =32.5) with metabolic syndrome, (3) Weight stability: <5% weight fluctuation in the 3 months prior to enrollment, and no prior systematic obesity treatment, (4) Patients with good compliance, who voluntarily participate in the study and sign the informed consent form, can strictly adhere to the dietary and lifestyle intervention plan and receive fecal microbiota transplantation (FMT) as scheduled.
Exclusion criteria
Exclusion criteria: (1) Absolute contraindications to fecal microbiota transplantation (FMT), including patients with severe intestinal barrier impairment (e.g., sepsis, active gastrointestinal hemorrhage, perforation), fulminant colitis, or immunodeficiency disorders, (2) Patients previously treated with immunosuppressants, antibiotics, or probiotics within 4 weeks, (3) Severe comorbidities, such as type II diabetes mellitus, major cardiovascular/cerebrovascular diseases, hepatic/renal insufficiency, malignancies, psychiatric disorders, or autoimmune diseases, (4) History of bariatric surgery or planned weight-loss procedures (e.g., liposuction) during the study; chronic use of anti-obesity medications, (5) Weight-affecting medications within 3 months prior to screening, including but not limited to: antidepressants, herbal medicines, metformin, GLP-1 receptor agonists, or SGLT-2 inhibitors, (6) Secondary obesity due to other causes (e.g., hypercortisolism), (7) Pregnancy or lactation, (8) Participation in other clinical trials within 4 weeks, (9) Other exclusions: FMT allergy, inability to comply with study procedures, or investigator-determined ineligibility.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in body weight, Body Mass Index, and waist circumference from baseline level; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in body fat-related indicators from baseline level: Waist-to-Height Ratio (WHtR) Waist-to-Hip Ratio (WHR) Body Fat Percentage (BFP) Body Fat Mass (BFM) Muscle Mass (MM) or Lean Body Mass (LBM);Changes in waist circumference, blood pressure, glucose metabolism (including fasting blood glucose, 2-hour postprandial glucose, and insulin resistance index), and lipid profile (including triglycerides and high-density lipoprotein cholesterol ) from baseline level;Changes in controlled attenuation parameter (CAP) and liver stiffness measurement (LSM) from baseline level;Changes in gut microbiota diversity;Changes in intestinal barrier function-related indicators: Changes in endotoxin levels and intestinal tight junction proteins (such as occludin, claudin-1) from baseline levels;Changes in Traditional Chinese Medicine Syndrome Score and quality of life score;Changes in inflammatory factors;Changes in gut microbiota metabolites; | — |
Countries
China
Contacts
Public ContactHao Lu
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed