Overview

It is currently unknown if the microorganisms (microbiota) in patients with ulcerative colitis (UC) is inherently dysfunctional, or if the inflammation created by the disease affects the microbiota.

Patients with UC have a higher level of sulfate reducing bacteria (SRB) compared to healthy people. This study is aiming to determine if the microbiota in patients with UC can be changed by engrafting donor SRB. This will be done following a fecal microbiota transplant (FMT), which is the process of transferring fecal microbiota from one individual to another.

Study Information

This study will have approximately 20 participants, who will be allocated at random to receive either a Fecal microbiota capsule daily for 8 weeks or a placebo. The study began on July 31st 2019 and is estimated to be completed on December 31st 2021.

Inclusion Criteria

• Able and willing to provide consent
• English speaking
• Diagnosis of ulcerative colitis based on typical clinical-histopathic diagnosis
• Diagnosis of ulcerative colitis of over 3 months
• Active disease on endoscopy (endoscopic Mayo subscore ≥ 1)
• Evidence of inflammation extending beyond a minimum of 20cm
• Any ongoing ulcerative colitis therapy must be at stable doses for 4 weeks prior to study and remain stable over the course of the study

Exclusion Criteria

• Extensive bowel resection
• Presence of ileostomy or colostomy
• Suspicion of ischemic colitis, radiation colitis or microscopic colitis
• Diagnosis of Crohn’s disease
• Diagnosis of per-anal fistula or abscess
• Adenomatous polyps that have not been removed
• Use of pre or probiotics within 30 days of randomization
• Pregnancy
• Severe food allergies
• End stage liver disease or cirrhosis
• An absolute neutrophil count < 500 cell/µL
• Life expectancy less than 6 months

Location

This study is located at the University of Minnesota in Minneapolis, Minnesota, United States. In order to participate, contact Amanda Kabage, M.S. on 612-624-2956 or kabage@umn.edu.

Sponsors / Collaborators

This study is sponsored by the University of Minnesota – Clinical and Translational Science Institute.