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

NCT07344428 | Not Yet Recruiting

• 1 other identifier: 2021ZSLYEC-127-CDED
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Crohn Disease

Keywords

Crohn's Disease Exclusion Diet; mucosal healing

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 14 (from baseline to week 14)

Secondary Outcomes (4)

• Clinical remission rate at week 14 (CDAI<150)

  Week 14 (from baseline to week 14)

• Endoscopic response rate at week 14 (SES-CD reduction ≥50%)

  Week 14 (from baseline to week 14)

• Transmural healing rate at week 14 (intestinal ultrasound)

  Week 14 (from baseline to week 14)

• Incidence of adverse events during 14-week treatment period

  Week 14 (from baseline to week 14)

Study Arms (2)

Crohn's Disease Exclusion Diet + Anti-TNF-α biologics

EXPERIMENTAL

Participants in this group 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.

Other: Crohn's Disease Exclusion Diet

Anti-TNF-α biologics only

NO INTERVENTION

Participants in this group will receive anti-TNF-α biologics alone (infliximab 5mg/kg IV at weeks 0, 2, 6, and 14, or adalimumab subcutaneous injection at standard doses) without any dietary intervention. This group serves as the control to evaluate the additional benefit of CDED when combined with standard biologic therapy. No specific dietary restrictions or guidance will be provided to this group.

Interventions

Crohn's Disease Exclusion Diet OTHER

Participants 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.

Crohn's Disease Exclusion Diet + Anti-TNF-α biologics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

Sixth afflicated of Sun-yat sen university

Guangzhou, Guangdong, 510655, China

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sixth Affiliated Hospital, Sun Yat-sen University

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 15, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)