Effects of Exclusive Enteral Nutrition on the Microbiome in Pediatric Inflammatory Bowel Disease
Condition: Inflammatory Bowel Diseases
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Observational

Summary: 
      Children with Crohn's disease can be effectively treated by remaining on a single-formula
      diet for 8 continuous weeks. This dietary therapy is known as "exclusive enteral nutrition"
      (EEN). It is just as effective as steroid treatment, which is what's traditionally used for
      the initial treatment of Crohn's disease. It is not clear why EEN is an effective treated.
      One possibility is that it changes the bacteria in our intestines, which allows the intestine
      to heal. It is also unclear whether EEN can be used to treat ulcerative colitis, a disease
      that is very similar to Crohn's disease. The purpose of our research project is to determine
      whether EEN can be used to treat ulcerative colitis, and understand how the intestinal
      bacteria changes while on EEN. Investigators will compare the results to patients who have
      either Crohn's disease or ulcerative colitis, and are receiving standard treatment for their
      disease (steroids). This is a pilot study, meaning that the goal of this study is to
      determine whether a larger study is feasible. Investigators will measure patient recruitment
      rates, whether patients are able to perform the treatment as requested, whether there are any
      safety concerns, and whether investigators are able to collect the bloodwork and stool
      samples without difficulty.
    

Detailed description: 
      Exclusive enteral nutrition (EEN) is an effective induction therapy in pediatric Crohn's
      disease (CD). Compared to corticosteroids, EEN has equivalent rates of clinical remission and
      significantly higher rates of mucosal healing and weight gain. There is a paucity of
      literature on the role of EEN in ulcerative colitis (UC). Some have postulated that colonic
      disease will not respond to EEN, yet two series found no difference in rates of clinical
      remission between small intestinal and colonic CD. The mechanisms underlying the
      effectiveness of enteral nutrition in colitis remain unclear. A microbiome-mediated
      pathogenesis is possible. Two studies have shown how EEN produces profound changes in
      microbial community structure within as little as 24 hours. These changes correlated with
      improved disease activity scores. Active inflammatory bowel disease also carries distinct
      microbial signatures. Baseline differences in taxonomy between IBD phenotypes may account for
      differences in EEN efficacy between CD and UC.

      The purpose of the pilot study is to investigate if EEN can be used for induction of
      remission of ulcerative colitis, and compare its usage to a) corticosteroids for UC and b)
      EEN or corticosteroids for Crohn's disease. The goal is to eventually characterize the
      clinical, biochemical and microbial changes that occur with each. However, given that EEN is
      a challenging commitment, as a sole source of nutrition for 8 weeks, investigators first have
      to evaluate feasibility in terms of participant recruitment, compliance and safety of this
      treatment. Both EEN and corticosteroid treatment require proper compliance to be effective,
      which can be a significant burden for the patient and his/her family. Investigators will
      therefore also determine satisfaction with the induction therapies and effect on quality of
      life. Further, since frequent follow up is being requested, investigators need to assess
      recruitment and retention rates, as well as compliance with completing bloodwork and
      providing stool samples. Investigators hypothesize that these induction therapies will be
      both feasible and safe. However, it is anticipated that, while patients will be satisfied
      with the treatment, it may have a significant impact on quality of life during those 8 week.
    

Intervention name(s): Exclusive Enteral Nutrition (EEN); Prednisone
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): Patients will be treated with 8 weeks of Exclusive Enteral Nutrition (EEN). Patients will continue to receive usual medical care, and concurrent IBD treatments will be permitted.; Patients will be treated with 8 weeks of prednisone (corticosteroid). Patients will continue to receive usual medical care, and concurrent IBD treatments will be permitted.
Other intervention name(s): Peptamen 1.5; Corticosteroid
Intervention MeSH terms: Prednisone
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric patients (<18yo) being followed and managed through the McMaster Children's
        Hospital's Division of Pediatric Gastroenterology. Patients are diagnosed with Crohn's
        Disease, Ulcerative Colitis, or Inflammatory Bowel Disease-Unclassified.
      
Biospecimen description: 
      Bl
    
Keywords: IBD; enteral nutrition; corticosteroids