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

Sponsor
Eighth Affiliated Hospital, Sun Yat-sen University
Study ID
NCT07599046
Status
Not Yet Recruiting

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Conditions

  • Obesity Type 2 Diabetes Mellitus

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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 Dates

Start date
Apr 30, 2026
Status verified
Apr 2026
Primary completion
Jan 30, 2027
Completion
Dec 30, 2029

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention group
    A comprehensive intervention combining fecal microbiota transplantation, calorie-restricted diet, and glucagon-like peptide-1 receptor agonist.
  • Active Comparator: Control group
    Conventional treatment with calorie-restricted diet and glucagon-like peptide-1 receptor agonist.

Primary Outcome Measure

Percent change in body weight [ Time Frame: From enrollment to the end of treatment at 24 weeks ]

Central Contacts

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