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

Opening soonNot applicableInterventional

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 60 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity Type 2 Diabetes Mellitus

Full registry criteria

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.

Treatments and study arms

Fecal microbiota transplantation (FMT)

Biological

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)

Drug

Semaglutide 1.0 mg subcutaneous injection once weekly

Calorie-restricted diet

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.

Primary outcomes

Percent change in body weightFrom enrollment to the end of treatment at 24 weeks

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.

Eighth Affiliated Hospital, Sun Yat-sen University🇨🇳 Shenzhen, Guangdong, China
Yunfeng Shen, Ph.DContact