A Pilot and Feasibility Study of Fecal Microbiota Transpl... | NCT02058524

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

NCT02058524

Sponsor

University of Chicago

Status

Terminated

Last Update Posted

Aug 24, 2016Estimated

Enrollment

1Actual

Phase

Phase 1

Conditions

Ulcerative Colitis

Interventions

fecal microbiota transplantation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Unable to recruit and enroll eligible subjects.

Expanded Access Info

Start Date

Jun 2013

Primary Completion Date

Jun 2016Actual

Completion Date

Jun 2016Actual

First Submitted Date

Aug 27, 2013

First Submission Date that Met QC Criteria

Feb 6, 2014

First Posted Date

Feb 10, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 23, 2016

Last Update Posted Date

Aug 24, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Label	Type	Description	Intervention Names
fecal microbiota transplantation	Experimental		Biological: fecal microbiota transplantation

Name	Type	Description	Arm Group Labels	Other Names
fecal microbiota transplantation	Biological		fecal microbiota transplantation	FMT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

ID	Term
D001691	Biological Therapy
D013812	Therapeutics