Crohn's disease of both small and large intestine Digestive System
Conditions
Interventions
Participants will be randomly assigned to receive either FMT or a placebo at four scheduled intervals: weeks 0, 4, 12, and 20. The placebo will consist of food-grade color mixed in normal saline. Both
Sponsors
Dayanand Medical College & Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: Patients with severe, penetrating and stricturing, or perianal fistulizing CD
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Clinical remission defined as a CDAI score of less than 150 at 24 weeks 2. Endoscopic response defined as a 50% reduction in the SES-CD score from baseline at 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Gut microbiome composition assessed via fecal metagenome analysis at baseline and week 24 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. | — |
Countries
India
Contacts
Public ContactAjit Sood
Outcome results
None listed