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

Phase 1

Terminated

• Conditions: Ulcerative Colitis
• Interventions: Biological: fecal microbiota transplantation

• Registration Number: NCT02058524
• Lead Sponsor: University of Chicago

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-08-27
• Study First Submitted QC: 2014-02-06
• Study First Posted: 2014-02-10
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-23
• Last Update Posted: 2016-08-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
fecal microbiota transplantation	fecal microbiota transplantation	-

Primary Outcome Measures

Name	Time	Method
Comparison of microbiome pre and post transplant	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.

Secondary Outcome Measures

Name	Time	Method
Tolerance of procedure	day 0 and day 7	Tolerability of colonoscopic FMT on Day 0 and Day 7 assessed by Tolerability Questionnaire
Adverse event frequency	6 months	Number of patients with reporting adverse events with type and severity of adverse events reported

Trial Locations

Locations (1)

University of Chicago Medicine; 🇺🇸 Chicago, Illinois, United States