Low Sulfur Fecal Transplant for Ulcerative Colitis

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the engraftment of donor microbiota's sulfate reducing bacteria (SRB) in subjects with active ulcerative colitis (UC) following sequential fecal microbiota transplant (FMT). Specifically this study will evaluate if low SRB donor microbiota translates to lower SRB microbiota in the UC recipient. It is widely unknown if the microbiota in UC is dysfunctional and therefore perpetuates inflammation, or if the ongoing inflammation shapes the microbiota. Patients with UC have a higher relative abundance of SRB compared to healthy controls. It is the aim of this study to determine if the microbiota in UC can be altered to favor a low SRB fraction.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Minnesota; University of Minnesota - Clinical and Translational Science Institute

Criteria

Inclusion Criteria:

• Able and willing to provide consent

• English speaking

• Diagnosis of ulcerative colitis based on typical clinical-histopathic diagnosis

• Diagnosis of ulcerative colitis > 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 < 6 months