Efficacy and Safety of CDED With Anti-TNF-α Biologics in Crohn's Disease

Crohn's disease (CD) is a chronic inflammatory bowel disease with high recurrence and surgical rates. Mucosal healing is a key therapeutic goal, yet current anti-TNF-α biologics achieve only about 30% mucosal healing. Dietary intervention, particularly the Crohn's Disease Exclusion Diet (CDED), shows promise in CD management. Preliminary data suggest that combining CDED with anti-TNF-α biologics may significantly improve mucosal healing rates (42.9% vs 25%). This single-center, prospective, randomized, controlled trial will enroll 185 adult CD patients with active disease (SES-CD ≥3), randomly assigned 1:1 to receive either anti-TNF-α biologics plus CDED or anti-TNF-α biologics alone. The primary endpoint is mucosal healing rate at week 14 (SES-CD=0). Secondary endpoints include clinical remission, endoscopic response, transmural healing, and adverse events. This study aims to provide high-quality evidence for the efficacy and safety of this combined approach in Chinese CD patients.

Inclusion Criteria: * Age ≥18 years. * Diagnosis of Crohn's disease confirmed by endoscopy and histopathology, with active disease (CDAI ≥150). * Indicated for anti-TNF-α biologic therapy (infliximab or adalimumab) and naïve to these agents. * Willing and able to provide written informed consent. * Able to understand and comply with study requirements, including dietary intervention and scheduled follow-up. Exclusion Criteria: * Presence of severe complications requiring surgical intervention (e.g., intestinal obstruction, intra-abdominal abscess, intestinal fistula). * Severe cardiac, hepatic, or renal insufficiency (e.g., Child-Pugh class C, or eGFR \20 mg/day). * Severe food allergies, celiac disease, severe malnutrition (BMI \