Sigall Boneh Rotem, Navas-López Víctor Manuel, Hussey Séamus, Pujol-Muncunill Gemma, Lawrence Sally, Rolandsdotter Helena, Otley Anthony, Martín-de-Carpi Javier, Abramas Lee, Herrador-López Marta, Egea Castillo Natalia, Chen Min, Hurley Michelle, Wingate Kirsten, Olen Ola, Eurenius Rääf Tintin, Yaakov Michal, Wierdsma Nicolette, Van Limbergen Johan, Wine Eytan
Pediatric Gastroenterology and Nutrition Unit, E. Wolfson Medical Center, Holon, Israel; Tytgat Institute for Liver and Intestinal Research, Amsterdam Gastroenterology Endocrinology and Metabolism, University of Amsterdam, Amsterdam, the Netherlands.
Pediatric Gastroenterology and Nutrition Unit, Hospital Regional Universitario de Málaga, Biomedical Research Institute of Malaga, Málaga, Spain.
Clin Gastroenterol Hepatol. 2024 Dec 26. doi: 10.1016/j.cgh.2024.12.006.
BACKGROUND & AIMS: The Crohn's disease exclusion diet (CDED) + partial enteral nutrition (PEN) is effective for inducing remission in mild-moderate Crohn's disease (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.
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).
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 (70%) of 30 for CDED compared with 16 (61.5%) of 26 for EEN (P = .5). At week 8, clinical remission was achieved in 23 (77%) of 30 CDED patients vs 14 (54%) of 26 EEN patients (P = .07), and 18 (60%) of 30 CDED patients vs 11 (42%) of 26 EEN patients maintained clinical remission to week 24 (P = .18). The body mass index Z score significantly improved in the CDED group but not in the EEN group.
The study was underpowered to show whether CDED was superior to EEN in sustaining remission. However, 2 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 body mass index Z score improved significantly in the CDED group but not in the EEN group (NCT02843100).
克罗恩病排除饮食（CDED）加部分肠内营养（PEN）对轻中度克罗恩病（CD）诱导缓解有效。我们评估了在轻至重度CD患者中，先进行2周的全肠内营养（EEN），然后采用CDED + PEN，与8周的EEN相比，在第14周维持临床缓解方面是否更具优势，以及CDED + PEN能否将缓解维持至第24周。
这项国际多中心随机对照试验将2周的EEN（Modulen IBD），随后进行3个阶段的CDED + PEN（以下简称CDED）与8周的EEN，随后进行PEN并自由饮食直至第24周（以下简称EEN）进行了比较。
在64名符合条件的患者中，56名被随机分组（由于新冠疫情导致目标招募失败，致使研究效能不足）：30名患者接受CDED，26名患者接受EEN。第14周的主要终点显示两组之间无显著差异，CDED组30名患者中有21名（70%）维持无皮质类固醇缓解，而EEN组26名患者中有16名（61.5%）维持缓解（P = 0.5）。在第8周，30名CDED患者中有23名（77%）实现临床缓解，而26名EEN患者中有14名（54%）实现临床缓解（P = 0.07），30名CDED患者中有18名（60%）维持临床缓解至第24周，而26名EEN患者中有11名（42%）维持临床缓解至第24周（P = 0.18）。CDED组的体重指数Z评分显著改善，而EEN组未改善。
该研究的效能不足以表明CDED在维持缓解方面是否优于EEN。然而，先进行2周的EEN，然后采用CDED对诱导CD缓解有效，大多数CDED患者维持缓解至24周。尽管24周内有饮食限制，但CDED组的体重指数Z评分显著改善，而EEN组未改善（NCT02843100）。
