FMT in Ulcerative Colitis-Associated Pouchitis

NCT ID: NCT02049502

Last Updated: 2019-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2018-02-01

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

Conditions

Ulcerative Colitis Associated Pouchitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

fecal microbiota transplant

fecal microbiota transplant

Group Type: EXPERIMENTAL

biologically active human fecal microbiota

Intervention Type: BIOLOGICAL

instillation of biologically active human fecal microbiota material via flexible sigmoidoscopy

sigmoidoscopy

Intervention Type: PROCEDURE

Interventions

biologically active human fecal microbiota

instillation of biologically active human fecal microbiota material via flexible sigmoidoscopy

Intervention Type: BIOLOGICAL

sigmoidoscopy

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia O. Shaffer

OTHER

Sponsor Role: lead

Responsible Party

Virginia O. Shaffer

M.D.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Virginia O. Shaffer, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University

Atlanta, Georgia, United States

Emory St. Joseph's Hospital

Atlanta, Georgia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00071015

Identifier Type: -

Identifier Source: org_study_id