The Crohn disease exclusion diet (CDED) with or without partial enteral nutrition may be effective for induction and maintenance of remission in adults with mild to moderate biologic naive Crohn disease (CD), according to results of a randomized clinical trial published in the Lancet Gastroenterology and Hepatology.
CD is mainly managed with immunosuppressive drugs that have additional side effects. There is an unmet need for safer therapies for patients with mild disease who are at a lower risk for complications and for patients who are ineligible for immunosuppressive treatments.
In the current open-label, randomized pilot trial (ClinicalTrials.gov Identifier: NCT02231814), investigators aimed to evaluate the efficacy of the CDED with or without partial enteral nutrition on induction and maintenance of remission in adults with CD.
The trial was conducted at 3 medical centers in Israel. Patients were screened from January 2017 to May 2020. The study included biologic naïve patients (n=44) aged 18 to 55 years with mild to moderate CD (defined by a Harvey-Bradshaw Index score of 5-14 points), maximal disease duration of 5 years, and with active disease confirmed on colonoscopy or imaging with increased inflammatory markers (C-reactive protein >5 mg/L or fecal calprotectin concentration >200 µ/g).
Patients were randomly assigned 1:1 to the CDED with partial enteral nutrition group (n=20) or the CDED alone group (n=24). The intention-to-treat (ITT) population included 19 and 21 patients from the CDED with partial enteral nutrition and CDED alone group, respectively, who received the intervention for at least 48 hours. The primary outcome was clinical remission at week 6 (defined as a Harvey-Bradshaw Index score of <5) in the ITT population.
Results of the study reported 68% (n=13/19) of patients receiving CDED with partial enteral nutrition and 57% (n=12/21) of patients receiving CDED alone achieved clinical remission at week 6 (P =.4618). Of the 25 patients achieving remission at week 6, 20 patients (80%) showed sustained remission at week 24; 12 patients were from the CDED with partial enteral nutrition group and 8 from CDED alone group.
Endoscopic remission at week 24 was observed in 14 patients (35%), of which 8 patients were from the CDED with partial enteral nutrition group and 6 from the CDED alone group. No serious adverse events were reported.
This trial was limited by the lack of a control group and the inclusion of a selective patient population who were more likely to be part of a dietary therapy trial. Additionally, exclusion of older patients, patients on steroids and biologics, and those who underwent surgery restricted study generalizability.
Researchers concluded, “[O]ur findings suggest that this diet could be used in adults with uncomplicated mild-to-moderate Crohn’s disease at diagnosis and possibly serve as a therapeutic alternative for patients who cannot receive medical therapy due to underlying health conditions.”
Disclosure: Some study authors declared affiliations with pharmaceutical and/or supplement companies. Please see the original reference for a full list of disclosures.
Yanai H, Levine A, Hirsch A, et al. The Crohn’s disease exclusion diet for induction and maintenance of remission in adults with mild-to-moderate Crohn’s disease (CDED-AD): an open-label, pilot, randomised trial. Lancet Gastroenterol Hepatol. 2022;7(1):49-59. doi:10.1016/S2468-1253(21)00299-5