Obesity and Metabolic Syndrome
Conditions
Interventions
FMT Treatment Group:FMT capsules, twice daily, 4 capsules each time, for 6 consecutive days per course, with a 3-week interval between courses, total of 3 courses
combined with lifestyle intervention (diet: daily energy intake 1300–1900 kcal, protein 20%–25%, fat 20%–30%, carbohydrates 45%–60%
exercise: at least 150 minutes of moderate-intensity aerobic activity or 75 minutes of high-intensity exercise per week, daily steps >=6000)
FMT Placebo Group:Placebo capsules, twice daily, 4 capsules each time, for 6 consecutive days per course, with a 3-week interval between courses, total of 3 courses
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 |
|---|---|
| Change in body weight, BMI, and waist circumference from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in body fat composition (waist-to-height ratio, waist-to-hip ratio, body fat percentage, fat mass, lean body mass);Improvement in metabolic syndrome parameters (waist circumference, blood pressure, glucose, lipid profile);Improvement in fatty liver disease (changes in CAP and LSM);Gut microbiota diversity indices (Shannon index, Simpson index);Intestinal barrier function (plasma endotoxin levels, occludin and claudin-1 expression);Inflammatory cytokines (IL-2, IL-4, IL-6, IL-10, IL-17, TNF-a, IFN-?, etc.);Gut microbiota-derived metabolites (TMAO, PAGLn, SCFA);Changes in Traditional Chinese Medicine symptom scores and quality of life scores;Safety outcomes (adverse events, vital signs, electrocardiogram, complete blood count, liver and renal function); | — |
Countries
China
Contacts
Public ContactLu Hao
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed