NCT02390726.

Trial name or title	Fecal Microbiota Transplant in the Treatment of ulcerative colitis (FMTUC)
Methods	Interventional (clinical trial), randomized
Participants	Inclusion Criteria: Men or women 18 to 75 years of age Established diagnosis of UC with known involvement of the left colon Mild to moderate disease defined as endoscopic evidence of disease with Mayo endoscopic sub‐score 1 or 2 and total Mayo score ranging from 4‐10 (the Mayo score ranges from 0 to 12, with higher scores indicating more severe disease. This score can be used for both initial evaluation and monitoring treatment response) Patients may be on any class of IBD‐related medication (excluding steroids) Patients must be on stable medication regimen for at least 6 weeks prior to enrolment Ability to understand and willingness to sign informed consent document Exclusion Criteria: Patients who are asymptomatic Patients with severe, refractory disease (defined as Mayo scores of > 10, or endoscopic disease activity score of > 3) or patients with any other significant condition which, in the opinion of the investigator, could confound or interfere with evaluation of safety, tolerability of the investigational treatment or prevent compliance with the study protocol Prior colectomy Positive stool test for any of the following: Clostridium difficile by PCR, Salmonella, Shigella, Yersinia, Campylobacter, enteropathogenic Escherichia coli by standard stool culture Use of the steroid medications (any formulation) in the prior 6 weeks to enrolment Systemic antibiotic use within prior 6 weeks to enrolment Regular probiotic supplement use within prior 48 hours to enrolment Pregnancy or breastfeeding Severe immunodeficiency, inherited or acquired (e.g. HIV, chemotherapy, or radiation therapy) History of anaphylaxis (severe allergic reaction) Documented allergy to fluoroquinolones, metronidazole Life expectancy less than 12 months Age less than 18 or greater than 75 years of age History of esophageal or gastric motility disorders
Interventions	Intervention FMT and microbial maintenance plus standard therapy Comparison: Sham FMT and sham microbial maintenance plus standard therapy
Outcomes	Primary Outcomes Assess Endoscopic Stages of the Colon Pre/Post FMT [Time Frame: 2 years] Assess endoscopic stage of the inflamed colon (endoscopic Mayo score) and assess the histologic stage of the biopsied colon (quiescent/mild/moderate/severe) pre and post FMT Assess Biologic Inflammatory Markers [Time Frame: 2 years] Assess biologic inflammatory markers (ESR, CRP, fecal calprotectin, and fecal lactoferrin) pre and post FMT Review and Track Patient reported Outcomes via Validated Questionnaires [ Time Frame: 2 Years ] Assess patient‐report outcomes (symptomatology and quality of life) calculated via validated questionnaires (symptomatic Mayo Score and SF36) Secondary Outcomes Change in metagenomic sequencing in Stool samples after FMT treatment [Time Frame: After 6, 12, and 18 Weeks ] Trace the effect FMT therapy has on microbiome diversity and to track whether this effect is sustained during and after therapy via metagenomic sequencing of stool samples at time 0, and weeks 6, 12, and 18
Starting date	December 2015
Contact information	Peter L Moses, MD
Notes	20 participants enrolled