Ulcerative ColitisPhase 1NCT03948919
Fecal Transplant for Ulcerative Colitis
A Phase 1 study testing Fecal microbiota in people with Ulcerative Colitis, run by University of Minnesota at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Fecal microbiota
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2019to 4 Jan 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
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.
Read the detailed description
Inflammatory bowel disease (IBD) is a chronic, relapsing remitting inflammatory disease of the intestine. The two main forms of IBD are Crohn's disease (CD) and Ulcerative Colitis (UC). There is no cure for IBD and the etiology is unknown, however IBD is thought to arise as an aberrant immune response to the intestinal microbiota. The intestinal microbiota closely correlates with inflammation in IBD. Currently, the treatment of IBD is based on suppressing the aberrant immune response in the intestine. This often takes the form of systemic immunosuppression, which in turn carries a multitude of risks including infection and malignancy. Thus there is an urgent need for safe, effective therapies that ultimately have the potential to cure IBD.
Fecal microbiota transplantation (FMT) is the process of transferring fecal microbiota from one individual to another. FMT has revolutionized the treatment of multiple recurrent Clostridium difficile infection with a cure rate around 90%. Given the success of FMT in C. difficile colitis, attention turned to other forms of colitis, in particular IBD. Early pilot studies demonstrated a mixed result for the use of FMT in IBD. One of the key issues surrounding the use of FMT in IBD is the challenge of engrafting a new microbiota. Additionally IBD flares following FMT for C. difficile infection have been reported, although it is difficult to account for the confounding of the underlying C. difficile infection. This study will examine how FMT donor selection can impact the engraftment of the microbiota into patients with UC.
- Conditions
- Ulcerative Colitis
- Being tested
- Fecal microbiota, Placebo
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal microbiotaDrug
Lyophilized encapsulated fecal microbiota given daily for 8 weeks.
PlaceboDrug
Placebo capsules identical in appearance to fecal microbiota capsules to be taken daily for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| FMT Treatment | Active comparator | Fecal microbiota - 1.0-3.0 x 10^11 CFU / day (2 capsules per day for 8 weeks). Receives: Drug: Fecal microbiota |
| Placebo | Placebo comparator | The placebo consists of a mixture of trehalose and crystalline methylcellulose (Avicel) in 6:1 (w/w) ratio that is packaged in size 0 swedish orange capsules, which are then double encapsulated in size 00 natural colored capsules to make them visibly indistinguishable from encapsulated active product. Two capsules taken daily for 8 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engraftment of donor microbiota
Engraftment measured by SourceTracker at baseline to week 12 between FMT arm and placebo arm.
Measured: 12 weeks
Secondary outcomes (4)
Clinical efficacy of FMT versus placebo
Change in partial Mayo score from baseline to week 8 between FMT and placebo arm
Measured: 8 weeks
Clinical efficacy of low sulfate reducing microbiota
Partial mayo score at week 12 between those with low sulfate reducing microbiota or not low sulfate reducing microbiota
Measured: 12 weeks
Rate of change of sulfate reducing microbiota
Change in quantitative PCR of sulfate reducing genes at week 1, 2, 3 and 4 between FMT arm and placebo arm
Measured: 4 weeks
Serious adverse events
Number of serious adverse events between FMT arm and placebo arm
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start31 Jul 2019
- Primary completion3 Nov 2023
- Study completion4 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Byron Vaughn, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03948919
- Sponsor's protocol ID
- GI-2019-27285
- Status last verified
- Jul 2025
- First submitted
- 10 May 2019
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Transplant for Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT03948919
- Acronym / sponsor ID
- GI-2019-27285
- Conditions
- Ulcerative Colitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 31 Jul 2019 (actual)
- Primary completion
- 3 Nov 2023 (actual)
- Study completion
- 4 Jan 2024 (actual)
- First posted
- 14 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Inflammatory bowel disease (IBD) is a chronic, relapsing remitting inflammatory disease of the intestine. The two main forms of IBD are Crohn's disease (CD) and Ulcerative Colitis (UC). There is no cure for IBD and the etiology is unknown, however IBD is thought to arise as an aberrant immune response to the intestinal microbiota. The intestinal microbiota closely correlates with inflammation in IBD. Currently, the treatment of IBD is based on suppressing the aberrant immune response in the intestine. This often takes the form of systemic immunosuppression, which in turn carries a multitude of risks including infection and malignancy. Thus there is an urgent need for safe, effective therapies that ultimately have the potential to cure IBD.
Fecal microbiota transplantation (FMT) is the process of transferring fecal microbiota from one individual to another. FMT has revolutionized the treatment of multiple recurrent Clostridium difficile infection with a cure rate around 90%. Given the success of FMT in C. difficile colitis, attention turned to other forms of colitis, in particular IBD. Early pilot studies demonstrated a mixed result for the use of FMT in IBD. One of the key issues surrounding the use of FMT in IBD is the challenge of engrafting a new microbiota. Additionally IBD flares following FMT for C. difficile infection have been reported, although it is difficult to account for the confounding of the underlying C. difficile infection. This study will examine how FMT donor selection can impact the engraftment of the microbiota into patients with UC.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FMT Treatment | Active comparator | Drug: Fecal microbiotaFecal microbiota - 1.0-3.0 x 10^11 CFU / day (2 capsules per day for 8 weeks). |
| Placebo | Placebo comparator | Drug: PlaceboThe placebo consists of a mixture of trehalose and crystalline methylcellulose (Avicel) in 6:1 (w/w) ratio that is packaged in size 0 swedish orange capsules, which are then double encapsulated in size 00 natural colored capsules to make them visibly indistinguishable from encapsulated active product. Two capsules taken daily for 8 weeks. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal microbiotaLyophilized encapsulated fecal microbiota given daily for 8 weeks. | Drug | FMT Treatment |
| PlaceboPlacebo capsules identical in appearance to fecal microbiota capsules to be taken daily for 8 weeks. | Drug | Placebo |
Primary outcome
Engraftment of donor microbiota
Time frame: 12 weeks
Engraftment measured by SourceTracker at baseline to week 12 between FMT arm and placebo arm.
4 secondary outcomes
Clinical efficacy of FMT versus placebo
Time frame: 8 weeks
Clinical efficacy of low sulfate reducing microbiota
Time frame: 12 weeks
Rate of change of sulfate reducing microbiota
Time frame: 4 weeks
Serious adverse events
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
Related trials for Ulcerative Colitis
Active, not recruitingObservational study
An Observational Prospective Long-term Exposure Registry of Adult Patients With Moderate-to-Severe Ulcerative Colitis
Ulcerative Colitis
RecruitingPhase 1/2
Safety, Dosage, and Microbiome Engraftment Study of MGT-006 for Ulcerative Colitis (ROOT Study)
Ulcerative Colitis (UC), Ulcerative Colitis, Active Moderate
RecruitingPhase 4
A Remotely Conducted Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically
Psoriasis, Colitis, Ulcerative
RecruitingPhase 3
A Study of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis
Colitis, Ulcerative
Not yet recruitingObservational study
A Study of Continued Use of Guselkumab in Participants With Crohn's Disease and Ulcerative Colitis in Real World Setting
Crohn Disease, Colitis, Ulcerative
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Byron Vaughn, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fecal microbiota in people with Ulcerative Colitis, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engraftment of donor microbiota (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.