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Effects of Exclusive Enteral Nutrition on the Microbiome in Pediatric Inflammatory Bowel Disease

NCT02521064 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 31

Last updated 2017-05-02

No results posted yet for this study

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.

Conditions

  • Inflammatory Bowel Diseases

Interventions

DIETARY_SUPPLEMENT

Exclusive Enteral Nutrition (EEN)

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.

DRUG

Prednisone

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.

Sponsors & Collaborators

  • Canadian Association of Gastroenterology

    collaborator INDUSTRY

  • McMaster Children's Hospital

    lead OTHER

Principal Investigators

  • Nikhil Pai, MD, FRCPC · McMaster University

Eligibility

Min Age
5 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • Canada

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02521064 on ClinicalTrials.gov