Health Condition 1: null- Patients of ulcerative colitis aged 18 - 65 years with mild to moderate disease activity
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with mild to moderate ulcerative colitis as assessed by Mayo Score (between 4 â?? 9) of any disease extent 2. Patients who are treatment naïve 3. Patients giving consent for FMT
Exclusion criteria
Exclusion criteria: 1. Patients with severe disease activity 2. Patients requiring hospitalization 3. Patients with H/O bowel surgery 4. Patients with concomitant GI infection 5. Pregnancy 6. Patients with other comorbid illnesses
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical remission at 8 and 24 weeks, defined as Mayo score â?¤2 with all sub-scores â?¤1Timepoint: 8 and 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Clinical response at 8 weeks and 24 weeks, defined as reduction in Mayo score by 3 points or by 30% reduction in Mayo score from baseline. â?¢ Endoscopic remission at 8 weeks, defined as Mayo endoscopic sub score of 0 â?¢ Patient reported outcome at 8 and 24 weeks as assessed by IBD-control questionnaire â?¢ Adverse events at 8 and 24 weeks. Timepoint: 8 and 24 weeks | — |
Countries
India
Contacts
AIIMS