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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorEighth Affiliated Hospital, Sun Yat-sen University

About this trial

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 criteria

Qualifiers

Age 18-60 years;

Body mass index (BMI) ≥30 kg/m² and <40 kg/m²;

Duration of type 2 diabetes mellitus <1 year;

Non-smoker or smoking cessation >3 months;

Disqualifiers

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);

Inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), or other organic intestinal diseases; autoimmune diseases, malignancies, or active infections;

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;

Others: Pregnant or lactating women; currently participating in other clinical trials.

Trial design

Treatments tested in this trial

  • Fecal microbiota transplantation (FMT)
  • Semaglutide (1 Mg Dose)
  • Calorie-restricted diet

Treatment groups

20 Participants
are divided into 2 treatment groups