Irritable bowel syndrome Irritable bowel syndrome
Conditions
Interventions
Capsule FMT,Colonoscope FMT
Experimental Procedure/Surgery,Active Comparator Procedure/Surgery
Sponsors
The gastroenterological association of Thailand
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Thai patients aged 18to 70 years who have been diagnosed with irritable bowel syndrome (IBS) according to the Rome IV criteria at the Outpatient Clinic, Division of Gastroenterology and Hepatology, Thammasat University Hospital
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding women. 2. Patients with fecal incontinence identified on physical examination. 3. Patients with severe comorbidities, including end-stage chronic kidney disease requiring renal replacement therapy , end-stage liver cirrhosis (ChildPugh classification grade C), immunodeficiency (AIDS), malignancy, and/or cerebrovascular disease or coronary artery disease. 4. Patients with immunodeficiency or those who have received immunosuppressive therapy within the past 3 months, including antineoplastic agents, monoclonal B- or T-cell antibodies, anti-TNF agents, antimetabolites (azathioprine, 6-mercaptopurine), calcineurin inhibitors (tacrolimus, cyclosporine), or mycophenolate mofetil. 5. Use of probiotics, probiotic-containing supplements or foods (including yogurt and fermented milk products), or fermented foods within the past 1 month, and unwillingness to discontinue these agents during study participation. 6. Discontinuation of medications used for the treatment of irritable bowel syndrome for less than 1 month prior to study enrollment. 7. Unwillingness to discontinue other investigational drugs during study participation. 8. Abnormal laboratory findings, including abnormal blood or stool test results. 9. Patients with contraindications to colonoscopy or rectal enema. 10. History of antibiotic use within 1 month prior to study enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ompare the efficacy of fecal microbiota transplantation using oral fecal capsules versus fecal microbiota transplantation delivered via colonoscopy in the treatment of irritable bowel syndrome. 12 weeks Change in IBS-SSS from baseline to post-treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare irritable bowel syndrome related quality of life 12 weeks measured by the Irritable Bowel Syndrome Quality of Life questionnaire (IBS-QOL), before and after treatment.,evaluate the adverse events associated with fecal microbiota transplantation administered via oral fecal capsules and via colonoscopy. 2 weeks Record adverse event ,investigate changes in the gut microbiota before and after fecal microbiota transplantation in patients with irritable bowel syndrome 12 weeks Stool fecal microbiota analyze | — |
Countries
Thailand
Contacts
Public ContactOmarit Saengsakul
Thammasat
Outcome results
None listed