Fecal Microbiota Transplant in the Treatment of Ulcerative Colitis

Recruitment & Eligibility

Inclusion Criteria

Men or women 18-75 years of age.
Established diagnosis of ulcerative colitis (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 enrollment.
Ability to understand and willingness to sign informed consent document

Exclusion Criteria

Patient 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 E. coli by standard stool culture.
Use of the steroid medications (any formulation) in the prior 6 weeks to enrollment
Systemic antibiotic use within prior 6 weeks to enrollment
Regular probiotic supplement use within prior 48 hours to enrollment
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.

Study & Design

Arm && Interventions

Group	Intervention	Description
Control	Placebo	Sham FMT and Sham Microbial Maintenance plus standard therapy
Treatment	Fecal Microbiota Transplant	FMT and microbial maintenance plus standard therapy

Primary Outcome Measures

Name	Time	Method
Review and Track Patient reported Outcomes via Validated Questionnaires	2 Years	Assess patient-report outcomes (symptomatology and quality of life) calculated via validated questionnaires (symptomatic Mayo Score and SF36)
Asses Endoscopic Stages of the Colon Pre/Post FMT	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.
Asses Biologic Inflammatory Markers	2 years	Assess biologic inflammatory markers (ESR, CRP, fecal calprotectin, and fecal lactoferrin) pre and post FMT.

Secondary Outcome Measures

Name	Time	Method
Change in metagenomic sequencing in Stool samples after FMT treatment	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.

Recruitment & Eligibility