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Not yet recruiting NCT07599046

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

No phase Interventional Obesity Type 2 Diabetes Mellitus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fecal microbiota transplantation (FMT), Semaglutide (1 Mg Dose), Calorie-restricted diet.
Who it may be relevant to
Registry conditions: Obesity Type 2 Diabetes Mellitus. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effects of Comprehensive Intervention With Fecal Microbiota Transplantation Versus Conventional Treatment on Body Weight and Metabolism in Patients With Obesity Complicated by Type 2 Diabetes Mellitus: A Randomized Controlled Trial

Overview

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.

Detailed 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).

Interventions

  • Biological Fecal microbiota transplantation (FMT)
    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.
  • Drug Semaglutide (1 Mg Dose)
    Semaglutide 1.0 mg subcutaneous injection once weekly
  • Behavioral Calorie-restricted diet
    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 outcome measures

  • Percent change in body weight [Time frame: From enrollment to the end of treatment at 24 weeks]
Secondary outcome measures (12)
  • The proportion of participants achieving ≥5% body weight reduction [Time frame: From enrollment to the end of treatment at 24 weeks]
  • Change in glycated hemoglobin (HbA1c) [Time frame: Baseline, Week 12, and Week 24]
  • Change in fasting insulin [Time frame: Baseline, Week 12, and Week 24]
  • Change in fasting plasma glucose [Time frame: Baseline, Week 12, and Week 24]
  • Change in total cholesterol [Time frame: Baseline, Week 12, and Week 24]
  • Change in low-density lipoprotein cholesterol [Time frame: Baseline, Week 12, and Week 24]
  • Change in high-density lipoprotein cholesterol [Time frame: Baseline, Week 12, and Week 24]
  • Change in triglycerides [Time frame: Baseline, Week 12, and Week 24]
  • Change in uric acid [Time frame: Baseline, Week 12, and Week 24]
  • Change in urinary albumin-to-creatinine ratio [Time frame: Baseline, Week 12, and Week 24]
  • Change in high-sensitivity C-reactive protein [Time frame: Baseline, Week 12, and Week 24]
  • Change in gut microbiota diversity indices [Time frame: Baseline, Week 12, and Week 24]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Eighth Affiliated Hospital, Sun Yat-sen University — Shenzhen

Identifiers

NCT: NCT07599046 · 2025-183-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗