FMT in Ulcerative Colitis-Associated Pouchitis
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|ClinicalTrials.gov Identifier: NCT02049502|
Recruitment Status : Active, not recruiting
First Posted : January 30, 2014
Last Update Posted : December 18, 2017
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:
- To see whether or not fecal microbiota transplantation (FMT) is a useful treatment for patients with ulcerative colitis (UC) associated pouchitis
- 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
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis Associated Pouchitis||Biological: biologically active human fecal microbiota Procedure: sigmoidoscopy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Use of Fecal Microbiota Transplantation in Patients With Ulcerative Colitis-associated Pouchitis|
|Study Start Date :||July 2014|
|Estimated Primary Completion Date :||February 2018|
|Estimated Study Completion Date :||March 2018|
Experimental: fecal microbiota transplant
fecal microbiota transplant
Biological: biologically active human fecal microbiota
instillation of biologically active human fecal microbiota material via flexible sigmoidoscopyProcedure: sigmoidoscopy
- 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
- favorable microbiota profile [ Time Frame: 3 months ]16s ribosomal gene sequencing and metabolomic profile of the gut microbiota
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02049502
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|Emory St. Joseph's Hospital|
|Atlanta, Georgia, United States, 30342|
|Principal Investigator:||Virginia O. Shaffer, MD||Emory University|