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

ICMR0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年11月21日

试验速览

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•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.

•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

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