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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
Sponsor:
Information provided by (Responsible Party):
Virginia O. Shaffer, Emory University

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:

  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 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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. favorable microbiota profile [ Time Frame: 3 months ]
    16s ribosomal gene sequencing and metabolomic profile of the gut microbiota



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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


Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Emory St. Joseph's Hospital
Atlanta, Georgia, United States, 30342
Sponsors and Collaborators
Virginia O. Shaffer
Investigators
Principal Investigator: Virginia O. Shaffer, MD Emory University

Responsible Party: Virginia O. Shaffer, M.D., Emory University
ClinicalTrials.gov Identifier: NCT02049502     History of Changes
Other Study ID Numbers: IRB00071015
First Posted: January 30, 2014    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: December 2017

Keywords provided by Virginia O. Shaffer, Emory University:
ulcerative colitis
fecal microbiota transplantation

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