CTRI/2022/10/046861Not yet recruitingPhase 3
The effect of a microbiome manipulation strategy through dietary exclusion and fecal microbial transplantation in inducing and maintaining remission in patients with mild to moderate Crohnâ??s disease - FMT-CD
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- ICMR
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1.Age between 18 â?? 70years
- •2.Patients with mild to moderate clinically active Crohnâ??s disease as assessed by CDAI (150 â?? 450)
- •3.Patients with terminal ileal/ ileocolonic (limited to terminal ileum)/colonic Crohnâ??s disease (i.e. L1, L2, or L3 disease as per Montreal classification)
- •4.Patients with inflammatory phenotype (B1) or structuring phenotype (B2) (with absence of stricture symptoms)
- •5.Evidence of active disease on objective measures including any of endoscopic activity (SES-CD >=3), fecal calprotectin ( >150 µg/gm), or radiological activity(within 3 months)
- •6.Patients giving consent for FMT
- •7.Patients who agree to adhere to the diet schedule
- •8.Patients on stable doses of azathioprine/ 6-mercaptoprine/methotrexate for 4weeks
- •9.Patients on stable doses of 5-ASA for 4 weeks
- •10.Patients not on steroids or on low dose steroids less than 20 mg daily of prednisone equivalent.
Exclusion Criteria
- •1.Patients with proximal small bowel disease (i.e. L4 disease)
- •2.Patients with severe disease activity
- •3.Patients with symptomatic strictures
- •4.Patients with H/O of antibiotic exposure in the past 2weeks
- •5.Patients with active perianal disease
- •6.Patients with abdominal abscess/ intestinal fistulae/ acute obstruction
- •7.Prior intestinal surgery (subtotal or total colectomy, ileostomy, colostomy) or patients planned for surgery (known fixed symptomatic stenosis or complex fistulae)
- •8.Patients who have been recently initiated (within 3 months) on biologicals or their regimen modified (such as increased frequency) within 3 months
- •9.Patients requiring hospitalization
- •10.Pregnancy
Investigators
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