Role of transplantation of fecal microbiota from healthy individuals to patients with Crohn's disease and its effect on achieving control of disease activity
Not Applicable
- Conditions
- Crohn's disease of both small and large intestineDigestive System
- Registration Number
- ISRCTN15318304
- Lead Sponsor
- Dayanand Medical College & Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
1. Patients with mild to moderate active CD, defined as CDAI 150-449
2. Ileal, ileo-colonic or colonic disease location
3. Inflammatory (non-penetrating non-stricturing disease behavior)
4. Diagnosis (endoscopic or radiographic and histological) of IBD at least 6 months prior to enrolment into the study
5. Subjects who are willing and able to comply with treatment plan, laboratory tests
6. Subjects who are willing to provide written informed consent
Exclusion Criteria
Patients with severe, penetrating and stricturing, or perianal fistulizing CD
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Clinical remission defined as a CDAI score of less than 150 at 24 weeks<br>2. Endoscopic response defined as a 50% reduction in the SES-CD score from baseline at 24 weeks
- Secondary Outcome Measures
Name Time Method 1. Gut microbiome composition assessed via fecal metagenome analysis at baseline and week 24<br>2. Safety and adverse events: adverse events related to FMT will be meticulously recorded using a pre-designed template throughout the study. The severity of these events will be graded according to the American Society of Gastrointestinal Endoscopy (ASGE) report criteria. This process will ensure comprehensive monitoring of any negative effects associated with the intervention.