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Fecal Microbiota Transplantation (FMT) Combined With Calorie-Restricted Diet and Semaglutide in Patients With Obesity and Type 2 Diabetes
Sponsor: Eighth Affiliated Hospital, Sun Yat-sen University
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.
Official title: Effects of Comprehensive Intervention With Fecal Microbiota Transplantation Versus Conventional Treatment on Body Weight and Metabolism in Patients With Obesity Complicated by Type 2 Diabetes Mellitus: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2026-04-30
Completion Date
2029-12-30
Last Updated
2026-05-20
Healthy Volunteers
No
Conditions
Interventions
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.
Semaglutide (1 Mg Dose)
Semaglutide 1.0 mg subcutaneous injection once weekly
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.
Locations (1)
Eighth Affiliated Hospital, Sun Yat-sen University
Shenzhen, Guangdong, China