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

NCT02521064 | Completed

• 1 other identifier: McmasterCH - 15-365
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

IBD; enteral nutrition; corticosteroids

Outcome Measures

Primary Outcomes (6)

• Feasibility: Participant recruitment rate

  Number of participants recruited per month

  Entirety of study (1 year)

• Feasibility: Participant retention rate

  Number of participants enrolled who did not complete the study

  Entirety of study (1 year)

• Feasibility: Participant compliance with intervention: treatment (EEN or corticosteroids)

  Number of participants who completed full treatment duration

  Entirety of study (1 year)

• Feasibility: Participant compliance with intervention: bloodwork, stool and urine sampling

  Number of blood, stool and urine sample collections per participant

  Entirety of study (1 year)

• Feasibility: Participant compliance with weekly interviews

  Number of weekly interviews completed per participant * Interviews discussing: a) disease assessment (Pediatric Ulcerative Colitis Activity Index \[PUCAI\]/Pediatric Crohn's Disease Activity Index \[PCDAI\] scores), and b) quality of life (health-related quality of life questionnaire)

  Entirety of study (1 year)

• Feasibility: Rate of adverse events in patients with ulcerative colitis receiving EEN

  Record of all adverse events

  Entirety of study (1 year)

Secondary Outcomes (4)

• Changes in microbiome (composite measure)

  Entirety of study (1 year)

• Clinical remission (composite measure)

  Entirety of study (1 year)

• Patient satisfaction and quality of life

  Entirety of study (1 year)

• Patient quality of life

  Entirety of study (1 year)

Study Arms (2)

Exclusive Enteral Nutrition (EEN)

The patient will be admitted to hospital for placement of the nasogastric tube and commencement of exclusive enteral nutrition (EEN). Nutritional feeds will consist of a semi-elemental (whey-peptide based) formula that will make up all of the patient's daily caloric needs (120% of BMR). Feeds will slowly be titrated up to full volume and strength during the hospital stay. The patient will receive instructions how to decrease the number of hours of feeds once at home. The patient will be seen in clinic at two weeks and will receive a phone call from the dietician at 4 weeks to assess progress and symptom improvement. At 8 weeks, food will start to be reintroduced slowly, as per the dietician's instructions.

Dietary Supplement: Exclusive Enteral Nutrition (EEN)

Prednisone

Patients who receive the prednisone intervention will follow the Division of Pediatric Gastroenterology and Nutrition protocol for corticosteroid induction therapy, with 2 weeks of high dose IV/PO prednisone (maximum 40mg/day) followed by a 6 week wean (approximately decreasing 5mg/day per week). The patient will receive a phone call from the nurse practitioner at two weeks and will be seen in clinic at 4 weeks to assess progress and symptom improvement.

Drug: Prednisone

Interventions

Exclusive Enteral Nutrition (EEN) DIETARY_SUPPLEMENT

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.

Also known as: Peptamen 1.5

Exclusive Enteral Nutrition (EEN)

Prednisone DRUG

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.

Also known as: Corticosteroid

Prednisone

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• Children 5-18 years old who have been diagnosed with IBD (confirmed by endoscopy, histology and radiography), and are followed by McMaster Children's Hospital's Division of Pediatric Gastroenterology and Nutrition.
• Patients requiring induction therapy
• Patients already taking 5-aminosalicylic acid (5-ASA) azathioprine, 6-mercaptopurine or anti-TNF (tissue necrosis factor) therapy (e.g. infliximab)

You may not qualify if:

• Patients who are in remission (on maintenance therapy).
• Patients who receive new medical therapies (e.g. antibiotics, probiotics) during the study period

Sponsors & Collaborators

• McMaster Children's Hospital: lead
• Canadian Association of Gastroenterology: collaborator

Study Sites (1)

McMaster Children's Hospital

Hamilton, Ontario, L8N3Z5, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Prednisone; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Nikhil Pai, MD, FRCPC

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident/fellow principal investigator

Study Record Dates

• First Submitted: July 29, 2015
• First Posted: August 13, 2015
• Study Start: July 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: May 2, 2017

Record last verified: 2017-04

Locations

CA (1)