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NCT Number: NCT02049502

FMT in 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

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Key information

Conditions

Ulcerative Colitis Associated Pouchitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Emory St. Joseph's Hospital, Atlanta, Georgia, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

biologically active human fecal microbiota

Biological

instillation of biologically active human fecal microbiota material via flexible sigmoidoscopy

sigmoidoscopy

Procedure

Primary outcomes

  1. Number of Patients Who Experienced Improvement of Pouchitis Symptoms

    Time frame: 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 outcomes

  1. Number of Patients With Favorable Microbiota Profile

    Time frame: 3 months

    16s ribosomal gene sequencing and metabolomic profile of the gut microbiota

Sponsors and collaborators

Lead sponsor

Virginia O. Shaffer

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jan 30, 2014
Registry last updated
Mar 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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