- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02521064
Effects of Exclusive Enteral Nutrition on the Microbiome in Pediatric Inflammatory Bowel Disease
The Role of Exclusive Enteral Nutrition in the Pediatric Inflammatory Bowel Disease Microbiome: a Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ontario
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Hamilton, Ontario, Canada, L8N3Z5
- McMaster Children's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Patients who are in remission (on maintenance therapy).
- Patients who receive new medical therapies (e.g. antibiotics, probiotics) during the study period
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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.
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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.
Other Names:
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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.
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility: Participant recruitment rate
Time Frame: Entirety of study (1 year)
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Number of participants recruited per month
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Entirety of study (1 year)
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Feasibility: Participant retention rate
Time Frame: Entirety of study (1 year)
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Number of participants enrolled who did not complete the study
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Entirety of study (1 year)
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Feasibility: Participant compliance with intervention: treatment (EEN or corticosteroids)
Time Frame: Entirety of study (1 year)
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Number of participants who completed full treatment duration
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Entirety of study (1 year)
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Feasibility: Participant compliance with intervention: bloodwork, stool and urine sampling
Time Frame: Entirety of study (1 year)
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Number of blood, stool and urine sample collections per participant
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Entirety of study (1 year)
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Feasibility: Participant compliance with weekly interviews
Time Frame: Entirety of study (1 year)
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Number of weekly interviews completed per participant
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Entirety of study (1 year)
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Feasibility: Rate of adverse events in patients with ulcerative colitis receiving EEN
Time Frame: Entirety of study (1 year)
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Record of all adverse events
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Entirety of study (1 year)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in microbiome (composite measure)
Time Frame: Entirety of study (1 year)
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Changes in microbial community structure in patients receiving EEN versus corticosteroid induction therapy.
Multiple indices of alpha and beta diversity will comprise composite assessment of microbiome change.
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Entirety of study (1 year)
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Clinical remission (composite measure)
Time Frame: Entirety of study (1 year)
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Effects of EEN therapy on induction of clinical remission in pediatric UC versus CD. Composite assessment consisting of:
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Entirety of study (1 year)
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Patient satisfaction and quality of life
Time Frame: Entirety of study (1 year)
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Patient satisfaction with the treatment (satisfaction validated questionnaire)
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Entirety of study (1 year)
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Patient quality of life
Time Frame: Entirety of study (1 year)
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Quality of life during induction therapy (quality of life validated questionnaire)
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Entirety of study (1 year)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Nikhil Pai, MD, FRCPC, McMaster University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Gastrointestinal Diseases
- Gastroenteritis
- Inflammatory Bowel Diseases
- Intestinal Diseases
- Physiological Effects of Drugs
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Prednisone
Other Study ID Numbers
- McmasterCH - 15-365
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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