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

Eighth Affiliated Hospital, Sun Yat-sen University

Status: Not yet enrolling

Conditions: Obesity Type 2 Diabetes Mellitus

Treatments: Drug: Semaglutide (1 Mg Dose); Behavioral: Calorie-restricted diet; Biological: Fecal microbiota transplantation (FMT)

Study type: Interventional

Funder types: Other

Identifiers

NCT07599046

2025-183-02

Details and patient eligibility

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.

Full description

This study is designed as a single-center, randomized, open-label, parallel-controlled trial. A total of 20 patients with moderate to severe obesity and T2DM (BMI 30-40 kg/m²) whose T2DM duration is less than one year will be enrolled, and randomly assigned to either the intervention group (FMT + ccalorie-restricted diet + semaglutide) or the control group (calorie-restricted diet + semaglutide). The intervention period will be 24 weeks. The primary endpoint is the percentage change in body weight from baseline to post-intervention. Secondary endpoints include the proportion of patients achieving a >5% weight loss, as well as metabolic parameters such as fasting blood glucose, lipid profile, glycated hemoglobin, visceral fat parameters, and gut microbiota diversity (Shannon/Simpson index).

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18-60 years;
2. Body mass index (BMI) ≥30 kg/m² and <40 kg/m²;
3. Duration of type 2 diabetes mellitus <1 year;
4. Non-smoker or smoking cessation >3 months;
5. Voluntary signed informed consent with commitment to complete the entire study.

Exclusion criteria

1. 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);
2. Inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), or other organic intestinal diseases; autoimmune diseases, malignancies, or active infections;
3. 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;
4. Others: Pregnant or lactating women; currently participating in other clinical trials.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Intervention group

Experimental group

Description:

A comprehensive intervention combining fecal microbiota transplantation, calorie-restricted diet, and glucagon-like peptide-1 receptor agonist.

Treatment:

Biological: Fecal microbiota transplantation (FMT)

Behavioral: Calorie-restricted diet

Drug: Semaglutide (1 Mg Dose)

Control group

Active Comparator group

Description:

Conventional treatment with calorie-restricted diet and glucagon-like peptide-1 receptor agonist.

Treatment:

Behavioral: Calorie-restricted diet

Drug: Semaglutide (1 Mg Dose)