Fecal microbiota transplantation (FMT): Donor Selection: Healthy lean donors with BMI \<23 kg/m² will be selected following rigorous health screening.
Capsule Preparation: Donor fecal samples will be homogenized, filtered to remove debris, lyophilized, and encapsulated in enteric-coated capsules.
Oral FMT capsule dosage: 10 capsules per dose, once daily, for 6 consecutive days each month.
Calorie-restricted diet: Daily caloric intake will be individualized based on physical activity level: 25 kcal/kg/day for individuals with light-to-moderate physical activity and 30 kcal/kg/day for those with heavy physical activity.
Study summary
Investigation of the efficacy of fecal microbiota transplantation added to calorie-restricted diet and semaglutide versus calorie-restricted diet and semaglutide alone for weight loss and metabolic improvement in patients with moderate to severe obesity and type 2 diabetes mellitus.
Eligibility
Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria:
1. Age 18-60 years;
2. Body mass index (BMI) ≥30 kg/m² and \<40 kg/m²;
3. Duration of type 2 diabetes mellitus \<1 year;
4. Non-smoker or smoking cessation \>3 months;
5. Voluntary signed informed consent with commitment to complete the entire study.
Exclusion Criteria:
1. Complicated with severe hepatic or renal insufficiency (alanine aminotransferase/aspartate aminotransferase \[ALT/AST\] \>3 times the upper limit of normal, or estimated glomerular filtration rate \[eGFR\] \<60 mL/min/1.73 m²);
2. Inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), or other organic intestinal diseases; autoimmune diseases, malignancies, or active infections;
3. Medication and intervention exclusions: Use of α-glucosidase inhibitors, antibiotics, proton pump inhibitors (PPIs), or probiotics/prebiotics within the past 3 months; bariatric surgery within the past 6 months; long-term use of immunosuppressants or glucocorticoids;
4. Others: Pregnant or lactating women; currently participating in other clinical trials.
Primary outcome measure(s)
Percent change in body weight — From enrollment to the end of treatment at 24 weeks The percentage change in body weight from baseline to follow-up visit (week 24) is presented. Body weight (kg) will be measured using a calibrated electronic scale operated by research personnel who have undergone standardized training.
Trial sites (1)
Facility
City
Region
Status
Eighth Affiliated Hospital, Sun Yat-sen University
Shenzhen
Guangdong
More Eighth Affiliated Hospital, Sun Yat-sen University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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