Whole Food Diet Induces Remission in Children and Young Adults With Mild to Moderate Crohn's Disease and Is More Tolerable Than Exclusive Enteral Nutrition: A Randomized Controlled Trial

Background & Aims: Tasty&Healthy (T&H) is a whole food diet for Crohn's disease (CD) that excludes processed food, gluten, red meat, and dairy, without requiring formula or mandatory ingredients. TASTI-MM was a clinician-blinded, randomized controlled trial comparing tolerability and effectiveness of T&H vs exclusive enteral nutrition (EEN). Methods: Patients with biologic-naïve mild to moderate CD and aged 6–25 years were randomized to either T&H or EEN for 8 weeks, receiving weekly dietary support. Tolerability was evaluated by weekly interviews, questionnaires, and intake diaries. Other outcomes included symptomatic remission, Mucosal-Inflammation Noninvasive index, calprotectin, C-reactive protein, and erythrocyte sedimentation rate. Fecal microbiome was analyzed by metagenomics at baseline, week 4, and week 8. Data were analyzed by the intention-to-treat approach unless specified otherwise. Results: Among 83 included patients (n = 41 T&H, n = 42 EEN; mean ± SD age, 14.5 ± 3.7 years), 88% tolerated T&H vs 52% for EEN (adjusted odds ratio [aOR], 7.7; 95% CI, 2.4–25; P < .001). Calprotectin, C-reactive protein, and erythrocyte sedimentation rate decreased significantly in both groups, with no between-group differences. Symptomatic remission was achieved in 56% of the T&H group vs 38% of the EEN group (aOR, 2.5; 95% CI, 0.98–6.3; P = .1; per-protocol: 67% vs 76%; P = .47). Calprotectin <250 μg/g was achieved in 34% vs 33% (aOR, 0.97; 95% CI, 0.37–2.6; P = .84) and Mucosal-Inflammation Noninvasive index score <8 in 44% vs 31% (aOR, 1.8; 95% CI, 0.7–4.5; P = .33). Microbiome α-diversity improved in the T&H arm and declined in the EEN arm, showing superior species richness at both week 4 and week 8. Species associated with bowel inflammation, such as Ruminococcus gnavus, decreased in T&H and increased in EEN (q < .001). Conclusions: T&H demonstrated better tolerability than EEN for inducing remission in mild to moderate CD, while positively affecting the microbiome. ClinicalTrials.gov, Number: NCT04239248.