Fecal Microbiota Transplantation in an Expanded Ulcerative Colitis Population

This is a randomized, double blind, placebo-controlled trial for UC patients with active disease.

Participants will be grouped into one of two categories

• Add to current therapy (i.e., adjunct therapy)

or

• Initiate or switch to a new advanced agent (i.e., co-administration)

The study will recruit 85 outpatients at 3 Canadian healthcare centres

Inclusion criteria

• 18 years of age or older
• Able to provide informed consent
• Established UC diagnosis through standard endoscopic and histologic criteria
• Active UC
• Use of effective contraception method for women of childbearing potential for at least 4 weeks prior to receiving study treatment and for the duration of the trial
• Willing and able to comply with all required study procedures

Exclusion criteria

• Severe UC requiring hospitalization
• Crohn's disease or indeterminate colitis
• Irritable bowel syndrome
• Intestinal infection within 4 weeks of enrollment
• Evidence of toxic megacolon or gastrointestinal perforation on imaging
• Planned colectomy
• Abdominal surgery within 60 days of enrollment
• Neutropenia with absolute neutrophil count <0.5 x 109/L
• Peripheral white blood cell count > 35.0 x 109/L and fever (>38C)
• Planned or actively taking another investigational product
• Uncontrolled medical conditions such as psychiatric disorders or substance abuse
• Severe underlying disease such that the patient is not expected to survive for at least 30 days
• Pregnancy or breastfeeding
• Unwilling to discontinue non-dietary probiotic
• Antibiotic use 30 days prior to enrollment or anticipated need for systemic antibiotic use during study
• FMT for any reason within 6 months of enrollment
• Investigator's judgement that enrolment is not in the best interest of the patient