Clinical Trial: FMT in Ulcerative Colitis-Associated Pouchitis
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: The Use of Fecal Microbiota Transplantation in Patients With Ulcerative Colitis-associated Pouchitis
Brief 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:
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Detailed Summary:
Sponsor: Virginia O. Shaffer
Current Primary Outcome: resolution of pouchitis symptoms [ Time Frame: 3 months ]
resolution of clinical pouchitis symptoms using the clinical component of the modified pouchitis disease activity index (mPDAI) without relapse
Original Primary Outcome: Same as current
Current Secondary Outcome: favorable microbiota profile [ Time Frame: 3 months ]
16s ribosomal gene sequencing and metabolomic profile of the gut microbiota
Original Secondary Outcome: Same as current
Information By: Emory University
Dates:
Date Received: January 27, 2014
Date Started: July 2014
Date Completion: August 2017
Last Updated: December 27, 2016
Last Verified: December 2016
