A Pilot and Feasibility Study of Fecal Microbiota Transplantation for Ulcerative Colitis

• Register: ClinicalTrials.gov
• Last refreshed on: 5 September 2016
• Main ID: NCT02058524
• Date of registration: 27/08/2013
• Prospective Registration: No
• Primary sponsor: University of Chicago
• Public title: A Pilot and Feasibility Study of Fecal Microbiota Transplantation for Ulcerative Colitis
• Scientific title: A Pilot and Feasibility Study of Fecal Microbiota Transplantation for Ulcerative Colitis
• Date of first enrolment: June 2013
• Target sample size: 1
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02058524
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Stacy Kahn, MD
• Affiliation: University of Chicago

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Biological: fecal microbiota transplantation

Primary Outcome(s)

Comparison of microbiome pre and post transplant [Time Frame: 12 weeks]

Secondary Outcome(s)

Tolerance of procedure [Time Frame: day 0 and day 7]

Adverse event frequency [Time Frame: 6 months]

Secondary ID(s)

IRB13-0212

Source(s) of Monetary Support

Please refer to primary and secondary sponsors