Assess utility of transferring healthy microorganisms to the large intestine of patients with mild to moderate Crohnâ??s disease

Phase 3

Conditions: Health Condition 1: K508- Crohns disease of both small andlarge intestine

Registration Number: CTRI/2022/10/046861

Lead Sponsor: ICMR

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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 Âµg/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