BACKGROUND: The Crohn's disease exclusion diet (CDED) has been shown to induce remission in adult Crohn's disease (CD) patients. The aim of the study is to provide additional evidence-based validation. METHODS: We conducted an open-label, randomized trial on adult CD patients with mild-to-moderate symptoms to assess CDED efficacy in inducing symptomatic remission using Mediterranean diet as control. We evaluate demographic data, body mass index (BMI), Harvey-Bradshaw Index (HBI), faecal calprotectin, and serum inflammatory indices at baseline, 12, and 24 weeks. Bioelectrical impedance analysis (BIA) was used to ensure the safety of the CDED group every 12 weeks. RESULTS: Twenty-four patients were assigned to CDED, and 21 to controls, with no baseline differences among the parameters considered. Five CDED patients dropped out due to intolerance within the first 6 weeks. At 12 weeks, CDED patients showed significantly lower HBI and higher remission rates than controls. By 24 weeks, remission rates increased (70.8% vs. 38.1% at 12 weeks and 79.2% vs. 42.9% at 24 weeks; p = .027 and p < .0001, respectively), with significantly lower fibrinogen levels in the CDED group. The administration of CDED was associated with a significant decrease in BMI (25.8 kg/m(2)-24.5 kg/m(2), p = .047), although BIA analysis showed a decrease in fat mass (18.2%-15.5%, p < .0001), while fat-free mass and body cellular mass significantly increased at 12 weeks (p = .001 and p = .042, respectively) and remained stable at 24 weeks. CONCLUSIONS: The CDED was effective in inducing remission among patients with mild-to-moderate CD and appeared to be safe and well-accepted.