Fecal Microbiota Transplantation Enema as a Noval Approach for Metabolic Syndrome: An Investigator-Initiated Randomized Sham-Intervention Study
- Conditions
- The gut microbiota plays a crucial role in various physiological processes, including metabolism. Fecal Microbiota Transplantation (FMT) involves transferring fecal matter from a healthy donor to rebalance the intestinal dysbiosis. While the impact of FMT on metabolic syndrome remains debatable.dysbiosis, enema, fecal microbiota transplantation, insulin resistance, metabolic syndrome
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 18
Adults aged 20-70 diagnosed with MetS according to the standards of the International Diabetes Federation and the American Heart Association/National Heart, Lung, and Blood Institute.
Exclusion criteria included severe chronic conditions such as end-stage kidney disease (with or without renal therapy), hepatic cirrhosis (Child-Pugh B/C), congestive heart failure, types 1 or 2 diabetes, immunodeficiency disorders, and use of immunosuppressants, chemotherapy, antibiotics, pre-/probiotics, or experimental drugs within the last 12 weeks. Other exclusions were prior gastrointestinal surgery affecting the anatomy, smoking, pregnancy, and breastfeeding.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean changes of insulin resistance marker 6 and 12 weeks Homeostatic Model Assessment for Insulin Resistance
- Secondary Outcome Measures
Name Time Method Other metabolic variables 6 and 12 weeks Body mass index, Fasting blood glucose, glycated hemoglobin level, lipid profiles,Adverse events 6 weeks Gastrointestinal symptoms such as nausea, vomiting, abdominal pain
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