Clinical trial NCT02058524: A Pilot and Feasibility Study of Fecal Microbiota Transplantation for Ulcerative Colitis
Official title: A Pilot and Feasibility Study of Fecal Microbiota Transplantation for Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Ulcerative Colitis
Keywords: Ulcerative Colitis
Fecal Microbiota Transplantation
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2014-02-10
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Comparison of microbiome pre and post transplant
timeFrame: 12 weeks
Secondary outcomes:
measure: Adverse event frequency
timeFrame: 6 months
measure: Tolerance of procedure
timeFrame: day 0 and day 7
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medicine
state: Illinois
Study officials:
affiliation: University of Chicago
name: Stacy Kahn, MD
role: PRINCIPAL_INVESTIGATOR
References: