Crohn Disease Clinical Trial
Official title:
Comparison of Partial and Exclusive Enteral Nutrition in the Treatment of Active Childhood-onset Crohn's Disease
The primary objective of this study is to determine the efficacy of a novel enteral
nutrition (EN) protocol (delivering 75% of patient's caloric needs through EN) for induction
of remission in patients with active childhood-onset Crohn's disease (CD) and compare it to
the standard protocol with exclusive enteral nutrition (EEN). This novel approach allows
patients to consume remaining calories (25%) from an antiinflammatory diet for CD (AID-CD).
The hypothesis is that no significant difference in the remission rate between the novel EN
protocol with partial enteral nutrition (PEN) and standard protocol with EEN will be
observed.
Background: Exclusive enteral nutrition (EEN) is a well established method of treatment for
inducing remission in childhood-onset Crohn's disease. It involves placing children on a
strict diet composed only of a single polymeric formula, as the sole source of nutrition
over 6 to 8 weeks. Use of this treatment method results in clinical remission in 50% to 80%
of children by week 6-8.
Partial enteral nutrition (PEN) would be more acceptable to patients than EEN, and might be
an effective treatment for active Crohn's disease. Moreover, there are studies suggesting
that PEN may be effective for the induction of remission in pediatric patients with Crohn's
disease; however, the level of evidence is still low.
Methods: This is a prospective randomized controlled trial, in patients with active
childhood-onset Crohn's disease comparing two arms over 6 weeks of therapy.
Group 1 (PEN group): will receive 75% of their dietary needs from a polymeric formula
(Alicalm, Nutricia) and a limited (25% of dietary needs = 1 meal per day) whole food AID-CD
for 6 weeks.
Group 2 (EEN group): will receive EEN with Alicalm (Nutricia) for 6 weeks.
Patients will be seen at onset and week 1, 3, and 6.
This study will evaluate clinical response (a decrease in PCDAI score of ≥12.5 points),
clinical remission (PCDAI <10) and mucosal healing using SES-CD in both groups, as well as
the effects of the two nutritional approaches on the patients' nutritional status.
Antiinflammatory diet for Crohn's disease (AID-CD) is based on reducing exposure to animal
fat, simple carbohydrates and processed food. We removed foods that previous research has
shown to induce inflammation and added foods that have been shown to be beneficial in
reducing inflammation. Our AID-CD is based on Central European and thus Slovenian local and
traditional cuisine.
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