Ulcerative ColitisPhase 1NCT02058524
A Pilot and Feasibility Study of Fecal Microbiota Transplantation for Ulcerative Colitis
A Phase 1 study testing fecal microbiota transplantation in people with Ulcerative Colitis, run by University of Chicago at 1 site in United States.
Trial summary
The investigators are conducting an open-label study of fecal microbiota transplantation (FMT) for adult patients with mildly-moderately active ulcerative colitis. In this pilot study the investigators will evaluate the feasibility, safety, and tolerability of a single application of FMT delivered colonoscopically. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- fecal microbiota transplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Jun 2016
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men or women, aged 18-65 years old
- Prior endoscopic confirmation of UC:
- Mildly to moderately active UC with Simple Clinical Colitis Activity Index (SCCAI) activity index >4-9
- Failing standard therapy with:
- stable doses of 5-ASA >2 weeks; thiopurines >3 months; or is steroid dependent at a dose <20mg/d; (inability to taper off steroid for longer than 1 week)
- Stable medications dose for at least 2 weeks prior to screening and upon entry into trial
- Ability to understand and willingness to sign informed consent document
Who cannot join
- Diagnosis of Crohn's disease, indeterminate colitis, or proctitis alone
- Severe or fulminate colitis
- Women who are pregnant or nursing
- Patients who are unable to give informed consent
- Patients who are unable or unwilling to undergo colonoscopy
- Patients who have previously undergone FMT
Show all 21Show fewer
- Patients who have a confirmed malignancy or cancer
- Patients who are immunocompromised
- Treatment within last 12 weeks with cyclosporine, tacrolimus, infliximab, adalimumab, certolizumab, natalizumab, thalidomide
- Antibiotic use within 2-months of start date
- Participation in a clinical trial in the preceding 30 days or simultaneously during this trial
- Probiotic use within 30 days of start date
- Rectal therapy within 14 days of start date
- Decompensated cirrhosis
- Congenital or acquired immunodeficiencies
- Other comorbidities including:
- Diabetes mellitus, cancer, systemic lupus, must be able to tolerate conscious sedation with colonoscopy
- Chronic kidney disease as defined by a GFR <60mL/min/1.73m2 (40)
- History of rheumatic heart disease, endocarditis, or valvular disease due to risk of bacteremia.
- Steroid >20mg/day
- Positive screening and confirmatory tests for HIV 1 \& 2, Hepatitis A, B, \& C, and Syphilis
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Medicine
Chicago, Illinois, 60637
About this study
The investigators are conducting an open-label study of fecal microbiota transplantation (FMT) for adult patients with mildly-moderately active ulcerative colitis. In this pilot study the investigators will evaluate the feasibility, safety, and tolerability of a single application of FMT delivered colonoscopically. The investigators will also characterize the impact of FMT on the microbiota of the recipient and determine if it correlates with the microbiota from the FMT donor.
- Conditions
- Ulcerative Colitis
- Being tested
- fecal microbiota transplantation
- Keywords
- Ulcerative Colitis, Fecal Microbiota Transplantation
- 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 microbiota transplantationBiological
Also called FMT
| Study group | Role | What they receive |
|---|---|---|
| fecal microbiota transplantation | Experimental | Not described Receives: Biological: fecal microbiota transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of microbiome pre and post transplant
We will analyze and compare the microbiome (bacterial populations) present pre- and post- transplant of the recipient. We will also analyze the microbiome of the donor and compare it to the donor microbiome pre- and post-FMT.
Measured: 12 weeks
Secondary outcomes (2)
Adverse event frequency
Number of patients with reporting adverse events with type and severity of adverse events reported
Measured: 6 months
Tolerance of procedure
Tolerability of colonoscopic FMT on Day 0 and Day 7 assessed by Tolerability Questionnaire
Measured: day 0 and day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2014 (estimated)
- Study startJun 2013
- Primary completionJun 2016
- Study completionJun 2016
Why it stopped: Unable to recruit and enroll eligible subjects.
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 ChicagoThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stacy Kahn, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02058524
- Sponsor's protocol ID
- IRB13-0212
- Status last verified
- Aug 2016
- First submitted
- 27 Aug 2013
- Last updated
- 24 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot and Feasibility Study of Fecal Microbiota Transplantation for Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT02058524
- Acronym / sponsor ID
- IRB13-0212
- Conditions
- Ulcerative Colitis
- Keywords
- Ulcerative Colitis, Fecal Microbiota Transplantation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit and enroll eligible subjects.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 10 Feb 2014 (estimated)
- 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 investigators are conducting an open-label study of fecal microbiota transplantation (FMT) for adult patients with mildly-moderately active ulcerative colitis. In this pilot study the investigators will evaluate the feasibility, safety, and tolerability of a single application of FMT delivered colonoscopically. The investigators will also characterize the impact of FMT on the microbiota of the recipient and determine if it correlates with the microbiota from the FMT donor.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fecal microbiota transplantation | Experimental | Biological: fecal microbiota transplantation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men or women, aged 18-65 years old
- Prior endoscopic confirmation of UC:
- Mildly to moderately active UC with Simple Clinical Colitis Activity Index (SCCAI) activity index >4-9
- Failing standard therapy with:
- stable doses of 5-ASA >2 weeks; thiopurines >3 months; or is steroid dependent at a dose <20mg/d; (inability to taper off steroid for longer than 1 week)
Key exclusion criteria (21 listed)
- Diagnosis of Crohn's disease, indeterminate colitis, or proctitis alone
- Severe or fulminate colitis
- Women who are pregnant or nursing
- Patients who are unable to give informed consent
- Patients who are unable or unwilling to undergo colonoscopy
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 microbiota transplantationAlso: FMT | Biological | fecal microbiota transplantation |
Primary outcome
Comparison of microbiome pre and post transplant
Time frame: 12 weeks
We will analyze and compare the microbiome (bacterial populations) present pre- and post- transplant of the recipient. We will also analyze the microbiome of the donor and compare it to the donor microbiome pre- and post-FMT.
2 secondary outcomes
Adverse event frequency
Time frame: 6 months
Tolerance of procedure
Time frame: day 0 and day 7
Results and safety
The study was stopped early (reason given: Unable to recruit and enroll eligible subjects.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2016.
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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.
Stacy Kahn, MD principal investigator
University of Chicago
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 transplantation in people with Ulcerative Colitis, run by University of Chicago 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 21 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: stopped early, as of the sponsor's last update on 24 Aug 2016. 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. 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 was stopped early (reason given: Unable to recruit and enroll eligible subjects.). Results are not available in the source record.
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?
Comparison of microbiome pre and post transplant (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 24 Aug 2016; AzTrials last refreshed its copy on 7 Nov 2026.