Fecal Microbiota Transplantation (FMT) Combined With Calorie-Restricted Diet and Semaglutide in Patients With Obesity and Type 2 Diabetes

What this study is testing ClinicalTrials.gov NCT07599046 ↗

Description as written by the study sponsor.

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.

Treatments tested

• Fecal microbiota transplantation (FMT) also known as FMT Biologic

  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) also known as glucagon-like peptide-1 receptor agonist, GLP-1 receptor agonist Drug

  Semaglutide 1.0 mg subcutaneous injection once weekly

• Calorie-restricted diet also known as CRD Behavioral

  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.