Health Condition 1: K508- Crohns disease of both small andlarge intestine
Conditions
Interventions
Intervention1: Fecal microbiota transplant plus crohns disease exclusion diet: Microbiome manipulation strategy consisting of
1. FMT via colonoscopy at 0, 2, 6, 12 weeks followed by 8 weekly during ma
Sponsors
ICMR
Eligibility
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Clinical remission [CDAI 150] 2. Endoscopic response [Decline in SES-CD score by 50% from baseline]Timepoint: 12 weeks (induction phase) and 52 weeks (maintenance phase) | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse eventsTimepoint: 12 and 52 weeks ;Clinical remissionTimepoint: 28 weeks;Endoscopic remission [absence of ulcerations in all segments and for isolated ileal CD: SES-CD 0-2]Timepoint: 12 weeks;Endoscopic response [Decline in SES-CD score by 50% from baseline]Timepoint: 28 weeks;Maintenance of steroid free clinical responseTimepoint: 52 weeks;Patient-reported outcome measures- PRO-3 questionaiireTimepoint: 52 weeks;Radiologic responseTimepoint: 52 weeks | — |
Countries
India
Contacts
Public ContactVineet Ahuja
All India Institute of Medical Sciences, New Delhi
Outcome results
None listed