Efficacy of Fecal Microbiota Transplantation (FMT) in Irritable Bowel Syndrome (IBS)
Efficacy of Fecal Microbiota Transplantation (FMT) in Irritable Bowel Syndrome (IBS): A Randomized, Placebo-controlled, Double-blind Study
Thammasat University
45 participants
Aug 19, 2020
INTERVENTIONAL
Conditions
Summary
The goal of this clinical trial is to determine efficacy of FMT via rectal enema and encapsulated FMT in patients with IBS in Thailand. The main question it aims to answer is: • Does FMT provide better efficacy than placebo in IBS patients? Participants will be randomized into 3 groups: * In placebo group, patients will receive placebo capsules and placebo via enema. * In enema group, patients will receive placebo capsules and FMT via rectal enema. * In capsule group, patients will receive FMT capsules and placebo via rectal enema. Researchers will compare FMT and placebo group to see if using FMT provides better efficacy for IBS patients than placebo. Moreover, researchers will compare efficacy of FMT capsules and FMT via rectal enema in IBS patients.
Eligibility
Inclusion Criteria2
- Patients aged 18-70 years with IBS diagnosed by Rome IV criteria
- Patients who can provide written informed consent.
Exclusion Criteria6
- Pregnant or breastfeeding women
- Severe comorbidities: chronic kidney disease (GFR<15 ml/min), cirrhosis, cancer, etc.
- Fecal incontinence
- Immunocompromised patients
- Taking probiotic, or fermented food
- Discontinue medication for IBS <1 month prior to study inclusion
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Interventions
50 grams of FMT via rectal enema
FMT capsules given twice daily for 2 consecutive days
Placebo via rectal enema
Placebo capsules given twice daily for 2 consecutive days
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06201182