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Fecal Microbiota Transplantation Enema as a Noval Approach for Metabolic Syndrome: An Investigator-Initiated Randomized Sham-Intervention Study

Phase 2
Completed
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
Registration Number
TCTR20240805004
Lead Sponsor
The Gastroenterological Association of Thailand (GAT)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
18
Inclusion Criteria

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

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
NameTimeMethod
Mean changes of insulin resistance marker 6 and 12 weeks Homeostatic Model Assessment for Insulin Resistance
Secondary Outcome Measures
NameTimeMethod
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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