For children with Crohn disease (CD), the Crohn disease exclusion diet (CDED) plus partial enteral nutrition (PEN) was found to be better tolerated than exclusive enteral nutrition (EEN), according to a study published in Gastroenterology.
Researchers conducted a postoperative trial of children aged 4 to 18 years with mild to moderate active luminal disease with 2 interventional arms comparing CDED plus 50% PEN (group 1) with EEN (group 2). Group 1 (n=40) received CDED plus 50% PEN for calculated energy requirement for weeks 1 to 6 followed by CDED plus 25% PEN for weeks 6 to 12. Group 2 (n=38) received EEN for 6 weeks followed by 25% PEN for weeks 6 to 12, with a gradual reintroduction of table foods between weeks 6 and 9. Patients were seen at baseline and at weeks 3, 6, and 12. Laboratory testing was conducted, including 16S ribosomal RNA gene sequencing of stool samples.
The primary end point was the patient’s tolerance to the diet by week 6 as indicated by the patient’s withdrawal from the study. Secondary end points included response, defined as a drop in pediatric CD activity index (PCDAI) of 12.5 points; remission at week 6; a decrease in or normalization of inflammatory markers at week 6; remission and normalization of C-reactive protein (CRP) at week 12; and poor adherence.
A total of 4 patients withdrew from the study because of intolerance, leaving 74 patients included for remission analysis. The combination of CDED plus PEN was tolerated in 39 children (97.5%), and EEN was tolerated by 28 children (73.6%). No statistically significant difference was found in response (85% vs 85.3%) and corticosteroid-free remission (80% vs 73.5%) between groups. Good adherence was associated with achieving remission for both CDED plus PEN and EEN.
No statistically significant difference was found in achieving normal CRP remission at week 6 between CDED plus PEN and EEN (51.3% vs 55.8%). However, normal CRP and corticosteroid-free remission at week 12 occurred in 22 (75.9%) of 29 patients receiving CDED plus PEN patients compared with 10 (47.6%) of 21 patients in the EEN group. More patients in the CDED plus PEN group than EEN patients were more likely to maintain remission (87.5% vs 56%, respectively). In children given CDED plus PEN, corticosteroid-free remission was associated with sustained reductions in inflammation and fecal Proteobacteria.
“These data support the use of CDED+PEN as first-line therapy for children with luminal mild to moderate active CD, and warrant further study to explore the role of diet in conjunction with drugs to optimize therapy in CD patients,” the authors concluded.
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Funding for this study was provided by Nestle Health Sciences. Please see the original reference for a full list of disclosures.
Levine A, Wine E, Assa A, et al. Crohn’s disease exclusion diet plus partial enteral nutrition induces sustained remission in a randomized controlled trial. Gastroenterology. 2019;157(2):440-450.