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

Starting soon · Not applicable

Conditions studied: Obesity Type 2 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT07599046

Run by

Eighth Affiliated Hospital, Sun Yat-sen University

People needed

20

Starts

2026-04-30

Expected to finish

2029-12-30

Last updated by the study team

2026-05-20

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;
• Voluntary signed informed consent with commitment to complete the entire study.

You may not qualify if…

• 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.

Where it is running

• Eighth Affiliated Hospital, Sun Yat-sen University — Shenzhen, Guangdong, China

Full record on ClinicalTrials.gov

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