Fecal Microbiota Transplantation in Pediatric Patients
Condition: Inflammatory Bowel Diseases (IBD); Crohn's Disease (CD); Ulcerative Colitis (UC)
MeSH terms: Crohn Disease; Colitis; Colitis, Ulcerative; Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      A disturbance in the diversity of gut bacterial composition could be linked to several immune
      mediated diseases including inflammatory bowel diseases (IBD). IBD can be classified into
      Crohn's Disease (CD) and Ulcerative Colitis (UC). Both these diseases occur from abnormal
      immune reaction to resident gut bacteria.The process of fecal microbiota transplantation
      (FMT) where fecal bacteria from a healthy individual is transferred into a recipient, has
      recently received attention as an alternative therapy for individuals affected with these
      life-altering diseases. In this study, the investigators will perform fecal transplantation
      on the subjects meeting inclusion criteria, to determine the efficacy and safety of this
      therapy in subjects with IBD (CD and UC) who are not responding to first line therapy, and
      are in a flare.
    

Detailed description: 
      50 subjects (25 subjects with Crohn's Disease and 25 subjects with Ulcerative Colitis) who
      are 2 to 22 years of age will be enrolled in the trial over 3 years. The fecal donors,
      preferably a parent or sibling, will be extensively screened for infectious diseases prior to
      providing stool for the transplant. Patients who are failing primary therapy, are in a flare,
      and require restaging of their IBD by an endoscopy and colonoscopy will be approached for the
      study. Standard of care endoscopy and colonoscopy will be performed on each subject and 2
      additional biopsies will be taken for analysis. Microbiota analysis will also be performed on
      both the donor and recipient stool sample prior to transplantation, and on the recipient
      sample at 1 week, 1 month, and 6 months post transplantation. The primary objective will be
      to study the safety of FMT in all enrolled subjects. The study will also correlate efficacy
      and patient outcomes with the fecal microbiome prior to, and after FMT. The secondary
      objectives are to examine the efficacy of FMT in the treatment of children with IBD using the
      Pediatric Ulcerative Colitis Activity Index (PUCAI) and the Pediatric Crohn Disease Activity
      Index (PCDAI) analysis. Correlate the patient outcomes with the fecal microbiome prior to,
      and after FMT.
    

Intervention name(s): Fecal Microbiota Transplantation (FMT)
Intervention type(s): Biological
Intervention description(s): The process of fecal microbiota transplantation (FMT), where fecal bacteria from a healthy individual is transferred into a recipient as an alternative therapy for individuals affected with these life-altering diseases: Crohn's Disease (CD), and/or Ulcerative Colitis (UC).
Other intervention name(s): Fecal Transplantation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Inflammatory Bowel Diseases (IBD); Crohn's Disease (CD); Ulcerative Colitis (UC)