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
Intervention: Fecal Microbiota Transplantation (FMT)
Intervention description: 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).
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 2 Years
Maximum age: 22 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Inflammatory Bowel Diseases (IBD); Crohn's Disease (CD); Ulcerative Colitis (UC)

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.
    

Eligibility criteria:

        STUDY SUBJECT INCLUSION CRITERIA:

        Current IBD patients who have:

          -  UC patients with a flare due to failure of current therapy and have to undergo
             esophagogastroduodenoscopy (EGD) and colonoscopy for restaging the disease and
             escalation of therapy.

          -  CD patients with ileo colonic or colonic disease who require an EGD and colonoscopy
             for disease assessment due to a flare or poor control.

          -  The ability to safely undergo colonoscopy (physical status classification used by the
             American Society of Anesthesiologists).

          -  PUCAI score less than sixty five.

          -  PCDAI score less than forty.

        STUDY SUBJECTS EXCLUSION CRITERIA:

          -  Patients with Crohn's disease: complications like an abscess, phlegmon, stricture,
             small bowel obstruction, perforation, internal or external fistulization or infection
             as causes for flare up before being deemed eligible for recruitment to the study. We
             will check for these complications if a recent study has not been done.

          -  Severe immunosuppression: Biologicals with concomitant steroids (>30 mg/day).

          -  Central Line.

          -  Pressor or ventilatory support.

          -  On antibiotics.

          -  Patients with Crohn's disease found to have complications like an abscess, phlegmon,
             stricture, small bowel obstruction, perforation, internal or external fistulization or
             infection.

          -  Not willing to consent or follow guidelines throughout research trial.

          -  Screening labs in either donor or recipient reveal problems with performing fecal
             microbiome transplantation because inclusion requirements are no longer met.

          -  Physician discretion.

          -  Participant request.

        DONOR EXCLUSION CRITERIA:

          -  A history of antibiotic treatment during the 3 months preceding donation.

          -  A history of intrinsic gastrointestinal illnesses.

          -  A history of autoimmune or atopic illness or modulating therapy.

          -  A history of chronic pain syndromes, or neurologic or neurodevelopmental disorders.

          -  Metabolic syndrome or malnutrition or obesity.

          -  A history of exposure to infectious agents.

          -  Diarrhea or other symptoms of an intestinal infection within two weeks prior to, or on
             the day of, stool donation.

          -  A history of malignant illnesses or ongoing oncologic therapy.

          -  Weight less than 15 kgs.