Fecal Microbiota Transplantation (FMT) for Treatment of Ulcerative Colitis in Children
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      Patients diagnosed with ulcerative colitis (UC), a specific type of inflammatory bowel
      disease, will be invited to take part in this study. The investigators do not know what
      causes UC. However, the microbes (such as bacteria and viruses), which normally live in our
      intestines are thought to play an important role in the development of UC. There are many
      treatment options for UC such as steroids,and other medications that decrease inflammation.
      However, none of these can cure the disease.

      This study aims to treat pediatric UC in an alternative fashion by changing the microbes in
      the gut by giving the participant's stool specimens from healthy adult individuals. There is
      some evidence from a few cases of adult UC that this therapy may cure the disease or at least
      provide long lasting suppression (remission) of the symptoms. The investigators would like to
      test this therapeutic intervention in children with UC.

      The purpose of this study is to (1) examine the microbiome of stool and colon (2) and to
      determine whether healthy-donated stool enemas can treat pediatric ulcerative colitis. (3)
      The investigators will also study the effects of the treatment on colonic gene expression.
    

Detailed description: 
      FMT RECIPIENTS:

      Participants will be recruited from the patient population treated by the Pediatric
      Gastroenterology, Hepatology, and Nutrition Section at Baylor College of Medicine/Texas
      Children's Hospital.

      I. Activities prior to starting FMT therapy:

        1. Participants will be asked to discontinue or taper their current home medications for
           ulcerative colitis.

        2. Participants will be asked to complete enema training.

        3. The participant and family will be counseled in case emergency surgical and/or intensive
           care interventions are required.

        4. Survey Completion to assess clinical symptoms.

      II. Initiation of FMT Therapy:

        1. Pre-colonoscopy and FMT therapy preparation:

           One to two days prior to scheduled colonoscopy the study participant will be asked to
           provide a stool sample. They will also undergo a bowel clean-out with Miralax for
           colonoscopy preparation. Colonoscopy (endoscopic examination of the large bowel) will be
           used to deliver the first donor fecal transplant at the beginning of the therapeutic
           protocol.

        2. FMT treatment and Initial colonoscopy:

      Fecal microbiota transplantation is made possible by utilizing a donor (healthy adult)
      providing their stool sample. The donor's stool will be screened and tested for known
      disease-causing agents including viruses, bacteria and parasites to prevent spread of disease
      to the participant.

      On the first day of treatment, the participant will undergo a colonoscopy to deliver the
      filtered donor stool directly into their colon. Additionally, biopsies will be taken during
      this procedure for routine diagnostic as well as research purposes.

      III. Subsequent FMT treatments:

      Enemas will be given periodically to complete a total of 1-year therapy.

      IV. Follow-up endoscopy and samples:

      A similar but more limited procedure (sigmoidoscopy) will be repeated at 14 weeks into the
      study period. Biopsies will be taken during this procedure for routine diagnostic as well as
      research purposes.

      FMT DONORS:

      Potential healthy adult stool donors (between 18 and 45 years of age) will be recruited by
      the research staff. They will be asked to volunteer for the screening and regularly supply
      stool samples according to the study protocol.
    

Intervention name(s): Fecal Microbiota Transplant
Intervention type(s): Biological
Intervention description(s): Fecal Microbiota Transplant will be endoscopically administered directly into the colon. Consecutive treatments will be given by rectal enema route.
Other intervention name(s): stool transplant
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stool transplant; Ulcerative Colitis; Fecal transplant; Inflammatory Bowel Disease