FMT in Ulcerative Colitis-Associated Pouchitis

NCT02049502 | Completed Phase 2 Results DMC

• 1 other identifier: IRB00071015
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

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. 1.To see whether or not fecal microbiota transplantation (FMT) is a useful treatment for patients with ulcerative colitis (UC) associated pouchitis
2. 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

Keywords

ulcerative colitis; fecal microbiota transplantation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Patients With Favorable Microbiota Profile

  3 months

Study Arms (1)

fecal microbiota transplant

EXPERIMENTAL

fecal microbiota transplant

Biological: biologically active human fecal microbiota; Procedure: sigmoidoscopy

Interventions

biologically active human fecal microbiota BIOLOGICAL

instillation of biologically active human fecal microbiota material via flexible sigmoidoscopy

fecal microbiota transplant

sigmoidoscopy PROCEDURE

fecal microbiota transplant

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia O. Shaffer: lead

Study Sites (2)

Emory University

Atlanta, Georgia, 30322, United States

Location

Emory St. Joseph's Hospital

Atlanta, Georgia, 30342, United States

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Sigmoidoscopy

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Colonoscopy; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Results Point of Contact

• Title: Dr. Shaffer
• Organization: Emory University

virginia.o.shaffer@emory.edu

404-778-5033

Study Officials

• Virginia O. Shaffer, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: January 27, 2014
• First Posted: January 30, 2014
• Study Start: July 1, 2014
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: March 27, 2019
• Results First Posted: March 19, 2019

Record last verified: 2019-03

Locations

US (2)