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

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02058524
• Other study ID #: IRB13-0212
• Status: Terminated
• Phase: Phase 1
• First received: August 27, 2013
• Last updated: August 23, 2016
• Start date: June 2013
• Est. completion date: June 2016

Study information

• Verified date: August 2016
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Biological:
• fecal microbiota transplantation

Locations

Country	Name	City	State
United States	University of Chicago Medicine	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks	No
Secondary	Adverse event frequency	Number of patients with reporting adverse events with type and severity of adverse events reported	6 months	Yes
Secondary	Tolerance of procedure	Tolerability of colonoscopic FMT on Day 0 and Day 7 assessed by Tolerability Questionnaire	day 0 and day 7	No