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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20240805004

Enrollment

Registered

2024-08-05

Start date

2023-06-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

FMT solutions were prepared using a single donor&#039

s stool sample. Over 2-3 minutes, we administered 200 mL of the FMT solution containing 50 gram of stool or the sham solution into the rectum and distal colon. ,Sham transplantation was carried out t

Active Comparator Biological/Vaccine,Sham Comparator Biological/Vaccine

FMT enema,Sham enema

Eligibility

Sex/Gender

All

Age

20 Years to 70 Years

Inclusion criteria

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: 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.

Design outcomes

Primary

Measure	Time frame
Mean changes of insulin resistance marker 6 and 12 weeks Homeostatic Model Assessment for Insulin Resistance	—

Secondary

Measure	Time frame
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	—

Countries

Thailand

Contacts

Public ContactSetthachai Piwchan

Thammasat University

setthachaipw@gmail.com0898603135

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026