NCT02734589.

Trial name or title	Pilot Study of Fecal Transplantation Using a Unique Diet for Donor and Recipient in Mild to Moderate Treatment Refractory Colitis in Inflammatory Bowel Disease
Methods	Interventional (Clinical Trial), randomized
Participants	Inclusion Criteria: Informed consent Established diagnosis of UC, disease confined to the large intestine, involving the rectosigmoid for at least 3 months Age: 18 ‐ 60 years ( inclusive) Mild to Moderate active disease, SCCAI of ≥5 and ≤11 with endoscopic subscore ≥ 2 Refractory to mesalamine for 6 weeks, or steroids > 14 days, or immunomodulator for 12 weeks or biologics for at least 12 weeks of therapy No use or stable use for 2 weeks of medical cannabis Exclusion Criteria: Start of a new biologic in the previous 12 weeks Evidence for Clostridium difficile infection Any proven current infection such as CMV, positive stool culture or parasite, Current extra intestinal manifestation of UC such as active arthritis or PSC Immune deficiency (other than drug induced) Current use of a calcineurin inhibitor Pregnancy Suspected toxic megacolon, guarding on palpation, or signs of peritoneal inflammation Patients with other IBD unrelated disease such as autoimmune disorders, renal failure, fever or current infection (UTI, strep throat, pneumonia, etc.) Prior or current neoplasia Fecal Transplantation in the last 6 months Fever > 38 degrees Participation in another clinical interventional trial An active malignant disease or a prior malignancy during the previous 5 years (excluding skin BCC) Inability or reluctance to use an enema Anticipation for antibiotic use within the study period (such as for elective surgery or dental treatment) Acute severe UC in the past 3 months Presence of a pouch or pouchitis
Interventions	Intervention: FMT with Diet for the donor and for the recipient Undergo standard fecal transplantation by colonoscopy on day 1 and 60 ml rectal enemas on days 2 and 14 with dietary pre‐conditioning of the donor for 14 days and dietary treatment of the recipient immediately after transplantation and for the following 12 weeks. Comparison I: Fecal microbiota transplantation (FMT) without Diet Undergo standard fecal transplantation by colonoscopy on day 1 and 60 ml rectal enemas on days 2 and 14 from the same donor without dietary conditioning. Comparison II: Dietary therapy only The patient will receive detailed instructions regarding the UC diet to be used over 12 weeks without FMT.
Outcomes	Primary outcome: Clinical remission determined by SCCAI score < 5 Secondary outcomes: Improvement in SCCAI score [Time Frame: Days 56 & 84] Mayo endoscopic score < 2 (for patients undergoing sigmoidoscopy) [Time Frame: Day 56] Fecal calprotectin < 250 µg/g [Time Frame: Day 56] The need for additional therapy [Time Frame: Week 12] according to the physician discretion Change in the microbiome compared to baseline [Time Frame: For donor‐ day 14 and for recipient day 56] according to analysis of fecal samples
Starting date	January 24, 2017
Contact information	Prof. Arie Levine, Director, Pediatric Gastroenterology and Nutrition unit., Wolfson Medical Center
Notes	Estimated enrolment: 34