NCT07344428Not yet recruiting
Efficacy and Safety of CDED With Anti-TNF-α Biologics in Crohn's Disease
Therapeutic Effect of Exclusion Diet Combined With Anti-TNF-α Biologics in Adult Patients With Crohn's Disease in China: A Single-center, Prospective, Randomized, Controlled Trial
Source: ClinicalTrials.gov · Last updated 10 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 185 (estimated)
- First submitted
- 7 Jan 2026
- Start date
- 1 Aug 2026
- Primary completion date
- 1 May 2028
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Diseases
- Crohn's disease
- NCT number
- NCT07344428
What you commit to
- Study type: Interventional
- Planned participants: 185
- From 1 Aug 2026 to the primary completion date, 1 May 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent use (within 3 months) of other immunosuppressants (e.g., azathioprine, methotrexate) or high-dose corticosteroids (e.g., prednisone \>20 mg/day).
- Concurrent participation in another clinical trial, or any condition that makes the patient unsuitable in the investigator's opinion.
Other illness
- Presence of severe complications requiring surgical intervention (e.g., intestinal obstruction, intra-abdominal abscess, intestinal fistula).
- Active tuberculosis, active hepatitis B, HIV infection, or other severe opportunistic infections.
- Current or history of malignancy, except non-melanoma skin cancer.
- Severe food allergies, celiac disease, severe malnutrition (BMI \<18.5 kg/m²), or inability to adhere to CDED.
Lab values
- Severe cardiac, hepatic, or renal insufficiency (e.g., Child-Pugh class C, or eGFR \<30 mL/min/1.73 m²).
Other
- Pregnant or breastfeeding, or planning pregnancy during the study period.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sixth afflicated of Sun-yat sen university Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.