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.
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.
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 <30 mL/min/1.73 m²).
Active tuberculosis, active hepatitis B, HIV infection, or other severe opportunistic infections.
Current or history of malignancy, except non-melanoma skin cancer.
Parallel
Crohn's Disease Exclusion Diet
Other interventionParticipants will receive anti-TNF-α biologics (infliximab 5mg/kg IV at weeks 0, 2, 6, and 14, or adalimumab subcutaneous injection at standard doses) combined with the Crohn's Disease Exclusion Diet (CDED). The CDED protocol includes detailed dietary guidance specifying allowed foods (rice, certain vegetables and fruits, fish, poultry, olive oil) and prohibited items (ultra-processed foods, nuts, legumes, butter). Patients will maintain daily food diaries and receive frequent supervision and guidance from researchers to ensure dietary compliance throughout the 14-week study period. This combined intervention aims to evaluate whether CDED can synergistically enhance the efficacy of standard biologic therapy in achieving mucosal healing in Crohn's disease patients.
Mucosal healing rate at week 14 (SES-CD=0)
The proportion of patients achieving complete mucosal healing, defined as a Simple Endoscopic Score for Crohn's Disease (SES-CD) score of 0 at week 14. SES-CD is a validated endoscopic scoring system that assesses the severity of mucosal inflammation in Crohn's disease, evaluating four parameters: ulcer size, ulcerated surface, affected surface, and presence of stenosis. A score of 0 indicates no visible inflammation or ulceration in the entire colon and terminal ileum, representing complete mucosal healing. Endoscopic assessments will be performed by experienced gastroenterologists who are blinded to treatment allocation.
Clinical remission rate at week 14 (CDAI<150)
The proportion of patients achieving clinical remission, defined as a Crohn's Disease Activity Index (CDAI) score less than 150 at week 14. CDAI is a validated clinical scoring system that evaluates eight parameters including number of liquid stools, abdominal pain, general well-being, extraintestinal manifestations, use of antidiarrheals, abdominal mass, hematocrit, and body weight. A score below 150 indicates clinical remission. Assessments will be performed by trained clinicians at each study visit.
Endoscopic response rate at week 14 (SES-CD reduction ≥50%)
The proportion of patients achieving endoscopic response, defined as a reduction of at least 50% in the Simple Endoscopic Score for Crohn's Disease (SES-CD) from baseline to week 14. SES-CD evaluates four endoscopic parameters in five colonic segments: ulcer size, ulcerated surface, affected surface, and presence of stenosis. A 50% reduction in total score indicates significant improvement in mucosal inflammation. Endoscopic evaluations will be conducted by blinded gastroenterologists.
Transmural healing rate at week 14 (intestinal ultrasound)
The proportion of patients achieving transmural healing, assessed by intestinal ultrasound with a maximum bowel wall thickness ≤3mm and absence of inflammatory signs. Transmural healing is defined as the normalization of bowel wall thickness and the resolution of inflammatory changes in the entire intestinal wall layers. Ultrasound examinations will be performed by experienced radiologists blinded to treatment allocation using standardized protocols.
Incidence of adverse events during 14-week treatment period
The incidence of all adverse events including diet-related malnutrition, allergic reactions, infusion reactions, injection site reactions, opportunistic infections, and other treatment-emergent adverse events. Adverse events will be monitored throughout the study period and graded according to the National Institute on Aging (NIA) severity criteria. Causality assessment will be performed by investigators using standardized criteria.
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