Efficacy and Safety of CDED With Anti-TNF-α Biologics in Crohn's Disease
Not applicable · Testing Crohn's Disease Exclusion Diet · 1 site · Sixth Affiliated Hospital, Sun Yat-sen University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Crohn's Disease Exclusion Diet as a possible treatment. Condition(s) listed: Crohn Disease.
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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.
Plus 2 more requirement(s). There are also 8 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 185 participants are expected to take part.
- Start date: 2026-08-01 (planned).
- Main results expected around 2028-05-01 (estimate from the record).
- 1 study site listed in China.
Main thing being measured
- Mucosal healing rate at week 14 (SES-CD=0) (Week 14 (from baseline to week 14))
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Crohn Disease |
| Lead sponsor | Sixth Affiliated Hospital, Sun Yat-sen University |
| Enrollment | 185 (estimated) |
| Start date | 2026-08-01 |
| Primary completion (est.) | 2028-05-01 |
| First posted | 2026-01-15 |
| Last updated | 2026-07-10 |
| Official title | 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 |
| ClinicalTrials.gov ID | NCT07344428 |
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,…
Full eligibility criteria (from the record)
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 <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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Sixth afflicated of Sun-yat sen university | Guangzhou, Guangdong | China |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.