FMT in Ulcerative Colitis-Associated Pouchitis

The Use of Fecal Microbiota Transplantation in Patients With Ulcerative Colitis-associated Pouchitis

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

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis Associated Pouchitis
• Intervention / Treatment: Procedure: sigmoidoscopy; Biological: biologically active human fecal microbiota

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
    • Atlanta, Georgia, United States, 30342
      • Emory St. Joseph's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: fecal microbiota transplant	Procedure: sigmoidoscopy; Biological: biologically active human fecal microbiota; instillation of biologically active human fecal microbiota material via flexible sigmoidoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients Who Experienced Improvement of Pouchitis Symptoms	Improvement of clinical pouchitis symptoms based on the clinical component of the modified pouchitis disease activity index (mPDAI) without relapse. These components include: stool frequency (number of stools), rectal bleeding, fecal urgency or abdominal cramps, or fever (temperature >37.8C).	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With Favorable Microbiota Profile	16s ribosomal gene sequencing and metabolomic profile of the gut microbiota	3 months

Collaborators and Investigators

• Sponsor: Virginia O. Shaffer
• Investigators: Principal Investigator: Virginia O. Shaffer, MD, Emory University

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: January 27, 2014
• First Submitted That Met QC Criteria: January 29, 2014
• First Posted (Estimate): January 30, 2014

Study Record Updates

• Last Update Posted (Actual): March 27, 2019
• Last Update Submitted That Met QC Criteria: March 18, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: fecal microbiota transplantation; ulcerative colitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Enteritis; Ileitis; Ileal Diseases; Ulcer; Colitis; Colitis, Ulcerative; Pouchitis
• Other Study ID Numbers: IRB00071015