FMT in Ulcerative Colitis-Associated Pouchitis

Phase 2

Completed

Conditions: Ulcerative Colitis Associated Pouchitis

Interventions: Biological: biologically active human fecal microbiota
Procedure: sigmoidoscopy

Registration Number: NCT02049502

Lead Sponsor: Virginia O. Shaffer

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 8

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
fecal microbiota transplant	sigmoidoscopy	fecal microbiota transplant
fecal microbiota transplant	biologically active human fecal microbiota	fecal microbiota transplant

Primary Outcome Measures

Name	Time	Method
Number of Patients Who Experienced Improvement of Pouchitis Symptoms	3 months	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).

Secondary Outcome Measures