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NCT07599046Not yet recruiting

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

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

Source: ClinicalTrials.gov · Last updated 20 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
20 (estimated)
First submitted
9 Apr 2026
Start date
30 Apr 2026
Primary completion date
30 Jan 2027
Lead sponsor
Eighth Affiliated Hospital, Sun Yat-sen University
NCT number
NCT07599046

What you commit to

  • Study type: Interventional
  • Planned participants: 20
  • From 30 Apr 2026 to the primary completion date, 30 Jan 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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;

Other illness

  • Inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), or other organic intestinal diseases; autoimmune diseases, malignancies, or active infections;

Lab values

  • 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);

Other

  • Others: Pregnant or lactating women; currently participating in other clinical trials.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Eighth Affiliated Hospital, Sun Yat-sen University
Coordinator of this site? Confirm its status
ShenzhenChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.