NCT03948919CompletedPhase 1
Fecal Transplant for Ulcerative Colitis
Source: ClinicalTrials.gov · Last updated 28 Jul 2025
Brief summary (registry, in English)
The purpose of this study is to evaluate the engraftment of donor microbiota with active ulcerative colitis (UC) following sequential fecal microbiota transplant (FMT). One key group of bacteria we are following are sulfate reducing bacteria (SRB). We plan to measure the relative abundance of SRB at baseline and after FMT. It is widely unknown if the microbiota in UC is dysfunctional and therefore perpetuates inflammation, or if the ongoing inflammation shapes the microbiota. We aim to determine if we can alter the microbiota in UC towards a healthy, more diverse microbiota resembling the donor using capsule FMT material.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 26 (actual)
- First submitted
- 10 May 2019
- Start date
- 31 Jul 2019
- Primary completion date
- 3 Nov 2023
- Lead sponsor
- University of Minnesota
- Diseases
- Ulcerative colitis
- NCT number
- NCT03948919
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 26
- From 31 Jul 2019 to the primary completion date, 3 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Extensive bowel resection
- Suspicion of ischemic colitis, radiation colitis or microscopic colitis
Other illness
- Diagnosis of Crohn's disease
- Diagnosis of per-anal fistula or abscess
- Severe food allergies
- End stage liver disease or cirrhosis
Lab values
- An absolute neutrophil count \< 500 cell/µL
Other
- Presence of ileostomy or colostomy
- Adenomatous polyps that have not been removed
- Use of pre or probiotics within 30 days of randomization
- Pregnancy
- Life expectancy \< 6 months
Who the study is looking for
- 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
Age in the registry: 18 years to 89 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.