ISRCTN15475780
Active, not recruiting
未知
The effect of microbiome manipulation through diet and Fecal Microbial Transplant (FMT) in inducing and maintaining remission in patients with mild to moderate ulcerative colitis: open label randomized controlled trial
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Mild to moderate ulcerative colitis
- Sponsor
- All India Institute of Medical Sciences
- Enrollment
- 66
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35973787/ (added 17/08/2022)
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Age between 18 – 65 years
- •2\. Patients with mild to moderate ulcerative colitis as assessed by simple clinical colitis activity index (SCCAI, 3 – 9\) of any disease extent along with active disease on endoscopy (ulcerative colitis index of severity, UCEIS \>1\)
- •3\. Patients on stable doses of 5\-ASA (5\-amino salicylic acid) for past 4 weeks
- •4\. Patients on stable doses of azathioprine/6\-mercaptopurine for past 3 months
- •5\. Patients who received biologics 6 months ago
- •6\. Patients on stable doses of topical therapy for past 2 weeks
- •7\. Patients on oral steroids (equivalent dose of prednisolone \<20 mg/day)
- •8\. Patients giving consent for FMT
- •9\. Patients who agree to adhere to the diet schedule
Exclusion Criteria
- •1\. Patients with severe disease activity
- •2\. Patients who have received topical 5\-ASA or topical steroids in the past 2 weeks
- •3\. Patients with H/O of antibiotic or probiotic exposure in the past 4 weeks
- •4\. Patients requiring hospitalization
- •5\. Patients with H/O bowel surgery
- •6\. Patients with concomitant GI infection
- •7\. Pregnancy
- •8\. Patients with other comorbid illnesses
Outcomes
Primary Outcomes
Not specified
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