Fecal Microbiota Transplantation in an Expanded Ulcerative Colitis Population
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alberta
About this trial
This is a multi-centre, randomised controlled trial comparing fecal microbiota transplantation to placebo in an expanded ulcerative colitis population: a feasibility study (FRONTIER-UC) to determine whether a full-scale randomized controlled trial (RCT) to investigate fecal microbiota transplantation (FMT) in ulcerative colitis (UC) is feasible.
Eligibility criteria
Qualifiers
18 years of age or older
Able to provide informed consent
Established UC diagnosis through standard endoscopic and histologic criteria
Active UC
Disqualifiers
Severe UC requiring hospitalization
Crohn's disease or indeterminate colitis
Irritable bowel syndrome
Intestinal infection within 4 weeks of enrollment
Trial design
Treatments tested in this trial
- Lyophilized Fecal Microbiota Transplantation (LFMT)
- Placebo
Treatment groups
85 Participants
are divided into 4 treatment groupsSponsors and collaborators
University of Alberta
Lead sponsor
University of Calgary
Collaborator
Source ClinicalTrials.gov