Clinical trial
Fecal Microbiota Transplantation (FMT) Combined With Calorie-Restricted Diet and Semaglutide in Patients With Obesity and Type 2 Diabetes
Opening soon · Not applicable · 1 countries · Registry ID NCT07599046
What this study is about
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.
Basic eligibility
Full registry criteria
Treatments and study arms
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.
Primary outcomes
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.
Study locations
1 locations were listed when this page was built. The first 40 are shown.