FMT in Ulcerative Colitis-Associated Pouchitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Emory University
Sponsor:
Information provided by (Responsible Party):
Virginia O. Shaffer, Emory University
ClinicalTrials.gov Identifier:
NCT02049502
First received: January 27, 2014
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

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

Condition Intervention Phase
Ulcerative Colitis Associated Pouchitis
Biological: biologically active human fecal microbiota
Procedure: sigmoidoscopy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Use of Fecal Microbiota Transplantation in Patients With Ulcerative Colitis-associated Pouchitis

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • resolution of pouchitis symptoms [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    resolution of clinical pouchitis symptoms using the clinical component of the modified pouchitis disease activity index (mPDAI) without relapse


Secondary Outcome Measures:
  • favorable microbiota profile [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    16s ribosomal gene sequencing and metabolomic profile of the gut microbiota


Estimated Enrollment: 11
Study Start Date: July 2014
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: fecal microbiota transplant
fecal microbiota transplant
Biological: biologically active human fecal microbiota
instillation of biologically active human fecal microbiota material via flexible sigmoidoscopy
Procedure: sigmoidoscopy

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male or female
  • age 18 to 65 years
  • ulcerative colitis-associated pouchitis
  • patients of Emory Clinic and/or Emory University Hospital

Exclusion Criteria:

  • Age <18 years or >65 years of age
  • Exposure to immunosuppressive therapy (defined as steroid, etanercept, or anti-tumor necrosis factor (TNF)agents) within 1 month prior to enrollment
  • Concomitant Clostridium difficile infection
  • Suspected Crohn's disease
  • Documented active infection of any kind
  • Patients on anti-coagulant therapy, with platelet count less than 50,000, significant anemia with hemoglobin less than 7 or those with other conditions that place them at increased risk of bleeding
  • Absolute neutrophil count (ANC) less than 1000 or history of opportunistic infection
  • Administration of investigational drug within one month prior to planned FMT
  • Pregnant or breastfeeding women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02049502

Contacts
Contact: Virginia O. Shaffer, MD 404-778-5809 virginia.o.shaffer@emory.edu

Locations
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Virginia O. Shaffer, MD    404-778-5033    virginia.o.shaffer@emory.edu   
Principal Investigator: Virginia O. Shaffer, MD         
Sub-Investigator: Colleen Kraft, MD         
Sub-Investigator: Tanvi Dhere, MD         
Sub-Investigator: Jahnavi Srinivasan, MD         
Emory St. Joseph's Hospital Not yet recruiting
Atlanta, Georgia, United States, 30342
Contact: David Weinstein, MD       david.harris.weinstein@emory.edu   
Sub-Investigator: David H. Weinstein, MD         
Sponsors and Collaborators
Virginia O. Shaffer
Investigators
Principal Investigator: Virginia O. Shaffer, MD Emory University
  More Information

No publications provided

Responsible Party: Virginia O. Shaffer, M.D., Emory University
ClinicalTrials.gov Identifier: NCT02049502     History of Changes
Other Study ID Numbers: IRB00071015
Study First Received: January 27, 2014
Last Updated: August 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Emory University:
ulcerative colitis
fecal microbiota transplantation

Additional relevant MeSH terms:
Ileal Diseases
Colitis
Colitis, Ulcerative
Ulcer
Pouchitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes
Ileitis
Enteritis

ClinicalTrials.gov processed this record on August 28, 2014