FMT in Ulcerative Colitis-Associated Pouchitis
Condition: Ulcerative Colitis Associated Pouchitis
MeSH terms: Colitis; Colitis, Ulcerative; Pouchitis; Ulcer
Intervention: biologically active human fecal microbiota; sigmoidoscopy
Intervention description: instillation of biologically active human fecal microbiota material via flexible sigmoidoscopy
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: ulcerative colitis; fecal microbiota transplantation

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
    

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