Diet meets biologics: accelerating remission in pediatric Crohn’s disease – a real-world experience

Background Exclusive enteral nutrition (EEN) and the Crohn’s disease exclusion diet (CDED) plus partial enteral nutrition (PEN) induce remission in pediatric Crohn’s disease (CD), but data on their use as adjuncts to biologic therapy remain limited. We aimed to determine whether CDED+PEN combined with first-line biologic therapy reduces the time to clinical and endoscopic remission, framed by STRIDE-II targets, compared with biologics alone. Methods Single-center, retrospective cohort study of pediatric patients with CD diagnosed per the revised Porto criteria who initiated first-line anti–tumor necrosis factor-α (anti–TNF-α) therapy between January 2020 and December 2024. Patients with significant comorbidities, inconsistent follow-up, or a change in biologic target were excluded. Group 1 (G1) received CDED+PEN (Modulen-IBD ® ) alongside biologics with multidisciplinary support; Group 2 (G2) received biologics alone. Outcomes were time to clinical response and to clinical remission, both defined by the weighted Pediatric Crohn’s Disease Activity Index (wPCDAI); time to normalization of erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP), time to fecal calprotectin (FC) normalization, and time to mucosal healing (MH). Absolute changes from baseline (Δ) in wPCDAI, FC, Simple Endoscopic Score for CD (SES-CD), ESR, CRP, albumin and body mass index (BMI) were compared between groups, and effect modification by disease location was assessed using median regression models including a diet-by-location interaction term. Between-group comparisons used the Mann–Whitney U test; time-to-event outcomes were analyzed using Kaplan–Meier methods with log-rank comparison. Results Forty patients were included (65% male; median age 12.02 years, interquartile range [IQR] 9.52–14.09): 27 in G1 and 13 in G2. Times to clinical response, clinical remission, and ESR/CRP normalization were consistently shorter in G1 without reaching statistical significance. FC normalization was achieved in 72.5% of patients overall and MH in 55.0%. Kaplan–Meier analysis showed no significant difference between groups in the cumulative incidence of either outcome (log-rank p = 0.82 for FC normalization and p = 0.54 for MH). At the prespecified time points, cumulative incidence of FC normalization at 4 months was 23.7% (G1) vs 30.8% (G2), and of MH at 12 months 16.0% (G1) vs 18.2% (G2). Among the absolute changes from baseline, wPCDAI was the only variable showing a significantly greater reduction in G1 (p = 0.029); Δ FC, SES-CD, ESR, CRP, albumin and BMI did not differ between groups. Disease location did not modify the effect of CDED+PEN on any outcome (all p for interaction > 0.10), although the small number of patients with isolated colonic disease (n = 10) renders this analysis exploratory. Conclusions In this real-world pediatric cohort, adding CDED+PEN to first-line biologic therapy was associated with a significantly greater reduction in wPCDAI, but not with improved cumulative incidence of FC normalization or MH. The incremental value of adjunctive dietary therapy in children already receiving a biologic may lie in earlier symptomatic control rather than in accelerated resolution of objective inflammation.