P716 A 2-week course of Exclusive Enteral Nutrition followed by the Crohn Disease Exclusion Diet is effective for Induction and Maintenance of Remission in children with Crohn Disease; the DIETOMICS-CD trial
Sigall-Boneh, R.(1,2)*;Manuel Navas-López, V.(3); Hussey, S.(4);Pujol Muncunill, G.(5);Lawrence, S.(6);Jonsson Rolandsdotter, H.(7,8);Otley, A.(9);Martín-de-Carpi5, J.(5);Abramas, L.(1);Herrador López , M.(10);Egea Castillo, N.(11);Chen, M.(12);Hurley, M.(13);Wingate, K.(14);Olen, O.(15,16);yaakov, M.(1);Levine, A.(1,17);Van Limbergen, J.(18,19);Wine, E.(12);
(1)The E. Wolfson Medical Center, Paediatric Gastroenterology and Nutrition Unit, Holon, Israel;(2)Tel-Aviv University, The Sackler Faculty of Medicine, Tel Aviv, Israel;(3)Hospital Regional Universitario de Málaga, Paediatric Gastroenterology and Nutrition Unit-, Málaga, Spain;(4)Royal College of Surgeons of Ireland and University College Dublin, National Children's Research Centre, Dublin, Ireland;(5)Hospital Sant Joan de Déu, Paediatric Gastroenterology- Hepatology and Nutrition Department., Barcelona, Spain;(6)BC Children's Hospital- University of British Columbia- BC, Paediatric Gastroenterology, Vancouver-, Canada;(7)Södersjukhuset- Karolinska Institutet- 11883, Department of Clinical Science and Education-, Stockholm, Sweden;(8)Sachs' Children and Youth Hospital- Södersjukhuset- 11883, Department of Gastroenterology, Stockholm-, Sweden;(9)IWK Health Center- - NS B3K 6R8, Division of Gastroenterology and Nutrition-, Halifax, Canada;(10)Hospital Regional Universitario de Málaga, Paediatric Gastroenterology and Nutrition Unit, Málaga, Spain;(11)Hospital Sant Joan de Déu, Paediatric Gastroenterology- Hepatology and Nutrition Department., - Barcelona, Spain;(12)University of Alberta, Departments of Paediatrics and Physiology, Edmonton, Canada;(13)Children’s Health Ireland - Crumlin, Children’s Health Ireland, Dublin, Ireland;(14)BC Children's Hospital- University of British Columbia - BC, Paediatric gastroenterology, Vancouver, Canada;(15)Sachs' Children and Youth Hospital- Södersjukhuset- 11883, Department of Gastroenterology, Stockholm, Sweden;(16)Karolinska Institutet., Clinical Epidemiology Division- Department of Medicine Solna-, Stockholm, Sweden;(17)Tel Aviv University, 2. The Sackler Faculty of Medicine, Tel Aviv, Israel;(18)Amsterdam University Medical Centers- Emma Children’s Hospital, Division of Paediatric Gastroenterology and Nutrition- Department of Pediatrics, Amsterdam, Netherlands Antilles;(19)Tytgat Institute for Liver and Intestinal Research- Academic Medical Center- University of Amsterdam, Amsterdam Gastroenterology Endocrinology and Metabolism, Amsterdam, Netherlands Antilles;
Background
Exclusive enteral Nutrition (EEN) is considered a first line therapy for children with active Crohn disease (CD). CD Exclusion Diet (CDED)+Partial Enteral Nutrition (PEN) is effective for induction of remission in mild-moderate CD at weeks 6 and 12, with better tolerance than EEN. We assessed whether a 2-week course of EEN, followed by CDED+PEN is superior to 8 weeks of EEN in sustaining clinical remission at week 14, outcomes of CDED up to 24 weeks, and the utility of CDED in mild-severe CD.
Methods
This international, multicenter, randomized-controlled trial compared 2 weeks of EEN (Modulen, Nestle Health Science) followed by 3 phases of the CDED+PEN to 8 weeks of EEN, followed by PEN with free diet, both up to week 24. Children aged 8-18 with CD<3 years, mild-severe disease [paediatric CD activity index (PCDAI) 15-47.5], and active inflammation [elevated C-reactive protein (CRP) or faecal calprotectin (FCP)] were included. Stable immunomodulator (IM) treatment was allowed. Naïve patients were allowed to start an IM from week 4.
Results
Of the 63 eligible patients enrolled, 55 were randomized and included in the final intention to treat analysis (target recruitment failed due to COVID); Group 1 (CDED+PEN;29) and group 2 (EEN;26), mean age 12.7±2.4. Steroids-free sustained remission at week 14 was obtained in 20/29(69%) in group 1 and 16/26(61.5%) in group 2, p=0.56. Remission at week 8 was obtained in 22/29(76%) in group 1 and 14/26(54%) in group 2, p=0.08. 16/29(55%) in group 1 and 9/26(34%) in group 2 maintained clinical remission at week 24; p=0.12. Median PCDAI declined from 32.5[20-36.2] to 2.5[0-5.6] and 1.2[0-5.6] in group 1 (p<0.001 for all), and from 22.5[20-29.3] to 0[0-4.3] and 0[0-2.5] in group 2 (p<0.005 for all) at baseline, week 8 and 14 respectively. Median CRP improved in group 1 from 32 mg/L[6-69] to 5[2-16] and 3[2-10.1] (p<0.001 for both) and in group 2 from 10.35 mg/L[5-33] to 3.7[2.2-7.2], p=0.012 and 3.2[2.8-5], p=0.006 at baseline, week 8 and 14 respectively. Median FCP declined in group 1 from 1946 µg/g [862-3304] to 802[196-1312] at week 8 and 241[82-1175] at week 14 (p<0.01 for both), and in group 2 from 1615[605-2692] at baseline to 436[252-1389] at week 8, which then increased to 731[349-1305] at week 14 (p<0.01 for both). At week 14, 12/22(54%) received IM from group 1 and 15/16(93%) from group 2; p= 0.009.
Conclusion
Two weeks of EEN followed by CDED&PEN and EEN were successful in induction of clinical and biochemical remission in mild-severe paediatric CD, and most CDED+PEN patients-maintained remission to 24 weeks. Sustained clinical remission at week 14 was similar despite higher IM use in the EEN Group, suggesting that CDED might prevents diet-induced inflammation regardless of IM use.