Fecal Microbiota Transplantation (FMT) Combined With Calorie-Restricted Diet and Semaglutide in P… (NCT07599046) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Fecal Microbiota Transplantation (FMT) Combined With Calorie-Restricted Diet and Semaglutide in Patients With Obesity and Type 2 Diabetes
China20 participantsStarted 2026-04-30
Plain-language summary
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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial combines three things at once — a fecal microbiota transplant, a calorie-restricted diet, and semaglutide — so could you help me understand which part is considered experimental here, and what risks come specifically from adding the FMT to the other two approaches?
2Since this trial is listed as 'not yet recruiting,' do you have a sense of when it might open, and whether waiting to see if I qualify would affect my current treatment for obesity and type 2 diabetes?
3The trial is listed as Phase NA, which I don't fully understand — does that mean the safety profile of this combined approach is less established than a Phase 2 or Phase 3 trial, and how should that affect my decision about whether to consider it?
4Semaglutide is already an approved medication I could potentially start now — would it make more sense for me to begin standard treatment right away rather than waiting for a trial that isn't open yet?
5Since the main thing being measured is percent change in body weight, how does that fit with my personal health goals around my type 2 diabetes, and would my blood sugar control also be tracked closely throughout the study?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percent change in body weight
Timeframe: From enrollment to the end of treatment at 24 weeks
Trial details
NCT IDNCT07599046
SponsorEighth Affiliated Hospital, Sun Yat-sen University
. 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.