NCT03006809.

Trial name or title	Optimal Fecal Microbiota Transplant Dosing for Mild to Moderate Ulcerative Colitis
Methods	Interventional (Clinical Trial), randomized
Participants	Inclusion Criteria: Patients with history of mild to moderate ulcerative colitis confirmed by endoscopy and pathology Total Mayo score 4‐9, endoscopic subscore ≥1; patients who have not had endoscopic evaluation within one year of enrollment will have flexible sigmoidoscopy for evaluation Age 18 to 64 years and deemed otherwise healthy at the discretion of the investigator Concurrent therapies with mesalamine (stable x 4 weeks), immunomodulators (stable x 3 months), and biologic agents (stable x 3 months) will be allowed to continue during study If patient is on prednisone, the dose must be ≤ 10mg/day at the time of treatment and will be weaned by 2.5mg/week during the study period Exclusion Criteria: Severe or refractory UC defined as Mayo score ≥10, endoscopic disease activity score 3; Untreated enteric infection (positive stool test for any of the following: Clostridium difficile, Salmonella, Shigella, Yersinia, Campylobacter, enteropathogenic E. coli or other enteric infection at the discretion of the investigator History of colectomy Disease limited to distal proctitis Patients taking probiotics within 6 weeks of planned FMT therapy Severe immunodeficiency, inherited or acquired (e.g. HIV, chemotherapy or radiation therapy) Patients with the following laboratory abnormalities: ANC < 1000 / µl, platelets < 50 x 10^9 /L, hemoglobin < 6.5 g/dL History of anaphylaxis (severe allergic reaction) to food allergens (e.g. tree nuts, shellfish) Dysphagia History of recurrent aspiration episodes Documented severe gastroparesis Active intestinal obstruction Patients with renal insufficiency (GFR < 50ml/min) Allergy to the following generally regarded as safe ingredients: glycerol, acid resistant HPMC, gellan gum, cocoa butter, titanium dioxide Adverse event attributable to any previous FMT Allergy/intolerance to proton pump inhibitor therapy Allergy/intolerance to vancomycin, metronidazole, or neomycin NSAIDs as long‐term treatment, defined as use for at least 4 days a week each month Cholestyramine use Any condition in which the investigator thinks the FMT treatment may pose a health risk (e.g. severely immunocompromised) Simultaneous participation in another interventional clinical trial Patients who are pregnant, breast feeding or planning pregnancy during study trial period Non‐use of appropriate contraceptives in females of childbearing potential; adequate by the responsible investigator during treatment) or well‐founded doubt about the patient's cooperation Patients with any other significant medical condition that could confound or interfere with evaluation of safety, tolerability or prevent compliance with the study protocol at the discretion of the investigator Life expectancy < 6 months
Interventions	Intervention: 1 Pretreatment antibiotics + FMT delivered by colonoscopy + FMT capsules per week x 6 weeks Intervention: 2 No antibiotics, FMT delivered by colonoscopy + FMT capsules per week x 6 weeks Intervention: 3 Pretreatment antibiotics + FMT delivered by colonoscopy + FMT delivered by enema once per week x 6 weeks Intervention: 4 No antibiotics, FMT delivered by colonoscopy + FMT delivered by enema once per week x 6 weeks
Outcomes	Primary Outcomes The occurrence of a serious adverse event, solicited and unsolicited adverse event, new gastrointestinal medical condition and diagnoses from FMT treatment or new infection from FMT treatment Steroid‐free clinical remission at week 9 + endoscopic remission or response defined as total Mayo score ≤ 2 with all four sub‐scores ≤ 1 and a ≥ 1 point reduction in endoscopy sub‐score Secondary Outcomes Changes in microbiome with FMT therapy Changes in the microbiome: assessed by frequent stool sampling for 16S rRNA analysis prior to each FMT therapy and after the last capsule/enema dose Clinical response: decrease in Mayo score by ≥ 3 points, decrease in bleeding subscore by ≥ 1, or absolute subscore of 0 or 1 Progression of disease defined by initiation of anti‐TNF agents or corticosteroids Initiation of anti‐TNF agents Progression of disease defined by increase in dosages of current UC medications Progression of disease defined by time to colectomy Time to death secondary to UC Progression of disease defined by clinical flare (time to next flare) Quality of Life Changes in Mood/Depression Score
Starting date	March 2, 2017
Contact information	Najwa Elnachef, Assistant Clinical Professor, University of California, San Francisco
Notes	Estimated enrolment: 40