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FMT in Ulcerative Colitis-Associated Pouchitis

NCT02049502 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2019-03-27

Study results available
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Summary

The purpose of this study is to test whether Fecal Microbiota Transplant (FMT) is a safe and effective treatment for people who have Ulcerative Colitis and have had an ileal pouch anastomosis.

Ulcerative colitis (UC) is a type of inflammatory bowel disease (IBD) that may be caused by a person's immune system responding in an unusual way to bacteria normally found in the gut. Studies have shown that the gut bacteria in people with ulcerative colitis (UC) are different from the gut bacteria in people without ulcerative colitis (UC). Often, people with ulcerative colitis (UC) have fewer types of bacteria in their gut which can change the way that person's immune system works.

This study is for people who have had a proctocolectomy with an ileal pouch anastomosis (IPAA) to treat ulcerative colitis (UC). More than 50% of people who have had an IPAA will develop a condition called pouchitis. Pouchitis is short or long-term inflammation of the ileal pouch that was created in order to store waste from your intestines. Patients with pouchitis are being asked to take part in this study.

Currently, antibiotics, probiotics and prebiotics are used to treat pouchitis. However, it has been shown that probiotics are not very helpful once the patient stops taking them. In addition, antibiotics may cause unfavorable side effects. Fecal microbiota transplantation (FMT) is being studied as another form of treatment for patients with active pouchitis. Fecal microbiota transplantation (FMT) or "stool transplant" involves receiving a single fecal enema from someone who has volunteered to donate their stool.

There are two purposes of this research study:

1. To see whether or not fecal microbiota transplantation (FMT) is a useful treatment for patients with ulcerative colitis (UC) associated pouchitis
2. To study the changes within the bacteria in the gut in patients with pouchitis (before and after study treatment) using stool, blood and urine samples

Conditions

  • Ulcerative Colitis Associated Pouchitis

Interventions

BIOLOGICAL

biologically active human fecal microbiota

instillation of biologically active human fecal microbiota material via flexible sigmoidoscopy

PROCEDURE

sigmoidoscopy

Sponsors & Collaborators

  • Virginia O. Shaffer

    lead OTHER

Principal Investigators

  • Virginia O. Shaffer, MD · Emory University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2018-02-01
Completion
2018-02-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02049502 on ClinicalTrials.gov