Efficacy and Safety of CDED With Anti-TNF-α Biologics in Crohn's Disease
Mucosal healing is an important treatment goal linked to better long-term outcomes, and current anti-TNF therapies achieve mucosal healing in a minority of patients. If adding CDED improves healing, it could offer a non-drug strategy to boost effectiveness of biologics.
Adults with Crohn's disease (especially those starting or on anti-TNF therapy), gastroenterologists and IBD dietitians, clinical researchers studying diet-drug combinations.
What To Know
This registered trial is testing whether adding the Crohn’s Disease Exclusion Diet (CDED) to standard anti-TNF therapy (infliximab or adalimumab) increases mucosal healing at 14 weeks compared with biologics alone—an outcome many people with Crohn’s disease and their clinicians prioritize.
This is a single-center, randomized, open-label trial in China enrolling 185 adults with active Crohn’s disease. Participants will receive infliximab or adalimumab at typical induction dosing; the intervention arm follows a standardized CDED with detailed allowed/prohibited foods and close dietary monitoring.
The primary endpoint is mucosal healing at week 14 (SES-CD = 0). Secondary endpoints include clinical remission, endoscopic response, transmural healing, and adverse events. Study practicalities: The trial excludes people with severe food allergies, celiac disease, severe malnutrition (BMI <18.5), or inability to adhere to the diet.
Diet adherence will be tracked through daily food diaries and frequent researcher supervision via WeChat and shared documents. This is a trial record (not results). The text cites preliminary data from the authors but the ClinicalTrials.gov entry describes a NOT_YET_RECRUITING interventional study, so no peer-reviewed results are reported here.
This is a trial record describing planned research; it does not report trial results. Preliminary data are mentioned but not presented as trial findings. The study is single-center and limited to Chinese adult patients, which may affect generalizability.
