Crohn's Disease Exclusion Diet Plus Partial Enteral Nutrition Induces Sustained Remission in a Randomized Controlled Trial
Abstract
BACKGROUND & AIMS
Exclusive enteral nutrition (EEN) is recommended for children with mild-to-moderate Crohn's disease (CD) but implementation is challenging. We compared EEN to the CD exclusion-diet (CDED), a whole-food diet coupled with partial enteral nutrition (PEN), designed to reduce exposure to dietary components that have adverse effects on the microbiome and intestinal barrier.
METHODS
We performed a 12-week prospective trial of children with mild to moderate CD. The children were randomly assigned to a group that received CDED plus 50% of calories from formula (Modulen, Nestlé) for 6 weeks (stage 1) followed by CDED with 25% PEN from weeks 7-12 (stage-2) (n=40, group 1) or a group that received EEN for 6 weeks followed by a free diet with 25% PEN from weeks 7-12 (n=38, group 2). Patients were evaluated at baseline and weeks 3, 6, and 12 and laboratory tests were performed. 16S rRNA gene (V4V5) sequencing was performed on stool samples. The primary endpoint was dietary tolerance. Secondary endpoints were intention to treat (ITT) remission at week 6 ( pediatric CD activity index score below 10) and corticosteroid-free ITT sustained remission at week 12.
RESULTS
Four patients withdrew from the study because of intolerance by 48 hours, 74 patients (mean age 14.2±2.7 years) were included for remission analysis. The combination of CDED and PEN was tolerated in 39 children (97.5%), whereas EEN was tolerated by 28 children (73.6%) (P=.002; odds ratio for tolerance of CDED…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 74 participants or records.
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