Authors E. SNOECK (1), E. VAN DE VIJVER (2), A. VAN GILS (2), N. MOES (2), I. HOFFMAN (3), B. HAUSER (4), G. VEEREMAN (4), R. DE BRUYNE (1), S. VAN BIERVLIET (1), M. VAN WINCKEL (1), S. VANDE VELDE (1) / [1] UZ Gent, Gent, Belgium, Pediatric gastro- enterology, [2] UZA, Universitair Ziekenhuis Antwerpen, Edegem, Belgium, Pediatric gastro- enterology, [3] UZ Leuven, Leuven, Belgium, Pediatric gastro- enterology, [4] Vrije Universiteit Brussel (VUB), Jette, Belgium, Pediatric gastro- enterology
Introduction ECCO and ESPGHAN recommend exclusive enteral nutrition (EEN) as first-line treatment in the management of mild to moderate Crohn’s disease (CD) in children. EEN requires an important patient commitment to adhere to exclusive liquid formula intake for 6 to 8 weeks. Modulife® combines 50% Crohn’s Disease Exclusion Diet (CDED) with 50% liquid formula intake. The addition of solid foods aims to improve diet adherence without compromising remission rate. The diet is designed to reduce dietary components with an adverse effect on the microbiome and intestinal barrier.
Aim The study objective was to evaluate the tolerability of Modulife® and its efficacy in induction of remission in pediatric CD.
Methods In this retrospective study we collected data from children diagnosed with mild to moderate CD from 4 IBD clinics in Belgium. Endpoints were dietary tolerance and remission at week 6 and 12 defined as PCDAI ≤ 10, according to the original study of Levine et al (2019).
Results Twenty-three children with mild to moderate CD were included in the analysis. Five out of 23 patients (22%) discontinued the Modulife® diet prematurely because of intolerance. Eighteen patients (78%) adhered to the diet. At week 6, 15 out of 18 children (83%) were in remission with PCDAI ≤ 10 and with an average decline in PCDAI of 21,5 points. At week 12, 15 out of 17 children (88%) were in remission with an average decline in PCDAI of 24,5 points. One child refused to continue the Modulife® dietary therapy after 6 weeks of use. 16 out of 23 children (70%) received azathioprine simultaneously.
Conclusions These preliminary retrospective observational results from 4 pediatric Belgian centers demonstrate that Modulife® is generally well tolerated with three quarters of the patients adhering to the diet. 88% of the patients who were able to maintain the diet were in corticoid free remission at week 12 with additional drug treatment. There are 2 important limitations of this study, namely the assessment of remission was based on PCDAI scores alone. We suggest to also take inflammatory markers and fecal calprotectin into account to assess remission in the following results of this study. There are few patients included, further patient enrollment is necessary to confirm these conclusions with longer follow-up.
