Modified Crohn's Disease Exclusion Diet Maintains Remission in Pediatric Crohn's Disease; Randomized Controlled Trial.

Background & Aims: The Crohn's Disease (CD) Exclusion Diet (CDED)+Partial Enteral Nutrition (PEN) is effective for inducing remission in mild-moderate CD. We assessed whether a 2-week course of Exclusive Enteral Nutrition (EEN), followed by CDED+PEN is superior to 8 weeks of EEN in sustaining clinical remission at week 14 in mild-to-severe CD and if CDED+PEN can maintain remission to week 24.

Methods: This international, multicenter, randomized-controlled trial compared 2-weeks of EEN (Modulen®IBD) followed by 3 phases of the CDED+PEN (henceforth CDED) to 8 weeks of EEN, followed by PEN with free diet up to week 24 (henceforth EEN).

Results: Out of 64 eligible patients, 56 were randomized (target recruitment failed due to the COVID-19 pandemic, leading to an underpowered study); 30 patients to CDED and 26 to EEN. The primary endpoint at week 14 showed no significant difference between the groups, with sustained corticosteroid-free remission in 21/30(70%) for CDED compared to 16/26(61.5%) for EEN, (p=0.5). At week 8, clinical remission was achieved in 23/30(77%) of CDED versus 14/26(54%) of EEN patients (p=0.07), and 18/30(60%) of CDED versus 11/26(42%) of EEN patients maintained clinical remission to week 24 (p=0.18). BMI Z-score significantly improved in the CDED group but not in EEN group.

Conclusions: The study was underpowered to show whether CDED was superior to EEN in sustaining remission. However, two weeks of EEN followed by CDED was effective in inducing remission in CD, with most CDED patients maintaining remission up to 24 weeks. Despite dietary restrictions for 24 weeks, the BMI Z-score improved significantly in the CDED group but not in the EEN group (NCT02843100).