P0436Crohn’s Disease Exclusion Diet (CDED) plus Partial Enteral Nutrition versus Oral Steroids for Induction and Maintenance of Remission in Adult Crohn’s Disease: A Prospective CaseControl Study

Background Systemic corticosteroids are effective for shortterm control of active Crohn’sdisease (CD) but carry relevant toxicity and poor durability. The Crohn’s Disease Exclusion Diet combined with partial enteral nutrition (CDED+PEN) has emergedas a steroidsparing option. We prospectively compared CDED+PEN with standard oral steroids for both induction and maintenance up to 24 weeks. Methods Thirtysix consecutive adults with active luminal CD were allocated 1:1 to CDED+PEN (ModuLife protocol) or oral steroids. At baseline the steroids grouphad longer disease duration (median 132 vs 13.5 months) and higher HBI (9.0vs 6.5); other variables were comparable. Clinical activity (Harvey–Bradshaw Index, HBI), Creactive protein, and faecal calprotectin were assessed at baseline, week 6, week 12, and week 24. The primary endpoint was steroidfree clinical remission(HBI < 5 without escalation) at week 24. Secondary endpoints included remissionat week 6, composite therapeutic success (remission + nosteroids/biologics + protocol adherence) and safety. Endoscopic assessment was scheduled for 12 months and is not reported here. Results Clinical response at week 6 occurred in 13/18 patients (72.2%) on CDED+PEN versus 12/18 (66.7%) on steroids (p = 0.72). By week 24, 10/18 CDED+PEN and 14/18 steroids patients completed followup. Steroidfree remission was achieved in 9/10 (90%) in versus 8/14 (57.1%), absolute difference 32.9% (p = 0.08). All CDED+PEN completers showed clinical response, and composite success was reached in 9/10 (90%) compared with 3/14 (21.4 %) controls (p = 0.001). No serious adverse events occurred and diet adherence remained ≥80% throughout. Conclusion CDED+PEN induced comparable response to steroids and maintained steroidfree benefit through 24 weeks, with higher success rate despite less advanced disease at baseline. These findings support CDED+PEN as an effective, safe, and patientaccepted alternative to steroids for induction and early maintenance in adult luminal CD and warrant confirmation in randomised trials. Conflict of interest: Prof. Ribaldone, Davide Giuseppe: No conflict of intereset Dileo, Ilaria: Chiarotto, Alessia: Ossola, Marta Gianna Franca Maria: Anrò, Marta: Avico, Anna: Consiglio, Valentina: Vernero, Marta: Bo, Simona: