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

Starting soon · Not applicable

Conditions studied: Crohn Disease

In brief

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.

Key facts

Study ID

NCT07344428

Run by

Sixth Affiliated Hospital, Sun Yat-sen University

People needed

185

Starts

2026-08-01

Expected to finish

2028-05-01

Last updated by the study team

2026-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Pregnant or breastfeeding, or planning pregnancy during the study period.
• Recent use (within 3 months) of other immunosuppressants (e.g., azathioprine, methotrexate) or high-dose corticosteroids (e.g., prednisone >20 mg/day).
• Severe food allergies, celiac disease, severe malnutrition (BMI <18.5 kg/m²), or inability to adhere to CDED.
• Concurrent participation in another clinical trial, or any condition that makes the patient unsuitable in the investigator's opinion.

Where it is running

• Sixth afflicated of Sun-yat sen university — Guangzhou, Guangdong, China

Full record on ClinicalTrials.gov

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