Abstract Background A 6-week Crohn’s Disease Exclusive Diet (CDED) combined with 1000kcal Partial Enteral Nutrition (PEN) and CDED alone are comparable in achieving clinical remission in patients with Crohn’s Disease (68% vs 57%, respectively, p = 0.46) suggesting that the CDED is effective without supplemental nutrition1. The exclusion of dairy products from the original CDED, despite the inclusion of dairy-derived ingredients (casein and milk fat) in PEN formulas, appears contradictory. This study aims to test whether the early introduction of dairy products maintains comparable efficacy to standard formula supplementation and to develop a more flexible CDED approach. Methods In this single-center RCT (NCT05606419), adult patients with active CD (Harvey-Bradshaw Index, HBI≥5) on stable therapy for at least 8 weeks prior to enrollment were randomized to receive either CDED plus PEN or CDED coupled with lactose-free, non-ultra-processed dairy products for 6 weeks. PEN and dairy products were incorporated into the recommended diets, each covering 50% of the energy requirements. The primary outcome was clinical response defined as HBI decrease ≥ 3 from baseline after 6 weeks. Secondary outcomes included clinical remission (i.e., HBI 5), changes in inflammatory markers faecal calprotectin (FC), CRP and quality of life (IBDQ). Results 21 patients were randomly assigned to either the PEN group (n = 10) or the Dairy group (n = 11). 17 out of 21 patients (9 PEN, 8 Dairy) completed the study (80.9%), showing high or very high adherence, regardless of the study group. In the intention-to-treat (ITT) analysis, clinical response was achieved in 15/21 (71.4%) of the total sample 8/10 (80%) in the PEN vs. 7/11 (63.8%) in the Dairy group, p = 0.635 and 16/21 patients (76.2%) achieved clinical remission at week 6. Among the 76.5% of the as-treated population who had at least one abnormal inflammatory marker at baseline (CRP ≥ 0.5 mg/dL and/or FC ≥ 100 μg/g), complete biochemical remission was achieved in 1/6 (16.7%) of the PEN group and 1/7 (14.3%) of the Dairy group (p = 1.000). FC data was available for 15 patients (8 PEN, 7 Dairy). More patients in the Dairy group achieved ≥ 50% FC drop 3/7 (42.9%) vs.1/8 (12.5%), p = 0.282, although the difference was not significant. IBDQ scores increased significantly in the total sample (p = 0.046), but there were no differences between the intervention groups (p = 0.943). Conclusion The CD-EDEN study suggests that CDED with early dairy introduction may be a viable alternative to CDED with standard formula supplementation, showing comparable clinical response rates and biochemical improvements in both groups. Larger trials are needed to establish non-inferiority and assess long-term efficacy. Reference: 1. Yanai H, Levine A, Hirsch A, et al. The Crohn’s disease exclusion diet for induction and maintenance of remission in adults with mild-to-moderate Crohn’s disease (CDED-AD): an open-label, pilot, randomised trial. Lancet Gastroenterol Hepatol. Jan 2022;7(1):49-59. doi:10.1016/s2468-1253(21)00299-5 Conflict of interest: Morogianni, Konstantina: Other: Sponsor of Study: Hellenic Group for the Study of IBD Karayiannis, Dimitrios: No conflict of interest Almperti, Avra: No conflict of interest Manolakis, Anastassios: No conflict of interest Viazis, Nikolaos: Nothing to declare Archavlis, Emmanuel: No conflict of interest Mantzaris, Gerassimos: Grant: AbbVie, Ferring, MSD, VIANEX Personal Fees: AbbVie, Aenorasis, BMS, Ferring, Genesis, Inovis, J&J, MSD, Pfizer, Takeda, Mylan, Vianex Other: AbbVie, Aenorasis, Amgen, BMS, Celtrion, CUBE, Falk Pharma, Faran, Ferring, Galenica, Genesis, J&J, MSD, Pfizer, Sandoz, TAKEDA, Vianex, Viatris Zampelas, Antonis: No conflict of interest Poulia, Kalliopi-Anna: No conflict of interest
Morogianni et al. (Thu,) studied this question.