FMT in Ulcerative Colitis-Associated Pouchitis

Study Overview
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Brief Summary
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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: To see whether or not fecal microbiota transplantation (FMT) is a useful treatment for patients with ulcerative colitis (UC) associated pouchitis 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

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

Conditions
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Ulcerative Colitis Associated Pouchitis

Intervention / Treatment
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* Biological: biologically active human fecal microbiota
* Procedure: sigmoidoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fecal microbiota transplant<br>fecal microbiota transplant | Biological: biologically active human fecal microbiota<br>* instillation of biologically active human fecal microbiota material via flexible sigmoidoscopy<br>Procedure: sigmoidoscopy<br> <br> |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ulcerative colitis, fecal microbiota transplantation