By Reuters Staff
NEW YORK (Reuters Health) - 5/7/2019
The combination of an exclusion diet plus partial enteral nutrition (PEN) induces sustained remission in children with mild-to-moderate Crohn's disease, according to results from a randomized controlled trial.
Exclusive enteral nutrition (EEN) is recommended as a first-line treatment in pediatric Crohn's disease, researchers note in Gastroenterology, online June 4. But this approach requires a firm commitment from the child and the family to avoid all other food intake for six to eight weeks, commonly requires the use of nasogastric tube feeding, and is infrequently used in North America, they add.
Dr. Johan Van Limbergen from Dalhousie University, in Halifax, Canada, and Amsterdam University Medical Center, in the Netherlands, and colleagues compared the tolerability and efficacy in inducing and sustaining corticosteroid-free remission of a Crohn's disease exclusion diet (CDED) coupled with PEN (group 1) versus standard EEN treatment (group 2) in their trial of 78 children with mild-to-moderate luminal Crohn's disease.
The CDED included five mandatory foods to promote changes in gut microbiota and included avoidance or reduction of exposure to foods containing animal/dairy fat, high fat from other sources, wheat, red or processed meat and protein sources rich in taurine, emulsifiers, artificial sweeteners, carrageenans and sulfites.
Besides the diet, participants in group 1 received patient education material with the CDED, recipes, and dietary instructions and were supported by a hotline managed by a research dietitian (at the site in Israel) as well as a dedicated study website (at the site in Canada), in addition to phone support between scheduled study visits. Participants in group 2 did not receive any such dietary instruction or support.
Four patients randomized to EEN withdrew within the first 48 hours after refusing to take the dietary formula (Modulen, from Nestle).
The primary endpoint of tolerance (remaining in the study through week 6) was significantly better in group 1 (39/40, 97.5%) than in group 2 (28/38, 73.7%).
At week 6, response rates were 85% in both groups, and there was no significant difference in corticosteroid-free remission (80% of group 1 vs. 73.5% of group 2, P=0.51).
There was also no significant difference in clinical remission rates by dietary therapy, but good compliance was strongly associated with achieving remission in both groups.
By week 12, significantly more patients in group 1 (28/37, 75.6%) than in group 2 (14/31, 45.1%) had sustained corticosteroid-free remission, with similar results after including only patients who had achieved corticosteroid-free remission by week 6 (87.5% vs. 56%, respectively).
Five children who crossed over to open-label CDED all achieved remission by week 6, and four of them maintained remission until week 12.
"These data support the use of CDED+PEN as a first-line therapy for children with luminal mild to moderate active Crohn's disease and warrant further study to explore the role of diet in conjunction with drugs to optimize therapy in Crohn's disease patients," the researchers conclude.
Nestle Health Science supported the study and provided Modulen to all participating sites. Several authors report ties to the company.
Dr. Van Limbergen did not respond to a request for comments.