Background: Oral viscous budesonide (OVB) using Splenda(R) as a delivery vehicle has become an attractive therapeutic option for children with eosinophilic esophagitis. However, many families are wary of giving the artificial sweetener in high doses to their children.
Specific Aim: To determine if OVB mixed with Neocate Nutra(R), a hypoallergenic nutritional supplement, is at least as efficacious as OVB mixed with Splenda(R) at healing eosinophilic esophagitis.
Methods: IRB approved retrospective chart review of patients with well documented eosinophilic esophagitis (EoE) treated with OVB at the Boston Children's Hospital Eosinophilic Gastrointestinal Disorder program between June 2008 and June 2013. Primary outcome measured was histologic response defined as change in peak eosinophil count to less than 15 eosinophils/HPF after at least 10 weeks of OVB therapy.
Results: Forty-six children were treated with OVB mixed with Splenda(R), and 14 were treated with OVB mixed with Neocate Nutra(R). The two groups were not significantly different in their demographic (race, age, gender) or clinical (initial eosinophil count, proton pump inhibitor use, or concomitant dietary elimination) characteristics.
On follow up endoscopy, 30 out of 46 patients on Splenda(R) and 13 out of 14 patients on Neocate Nutra(R) achieved histologic response. Mean pre- and post- treatment peak eosinophil counts for the children taking Neocate Nutra(R) were 62 eos/HPF (range, 20-120 eos/HPF) and 9 eos/HPF (range, 0-100 eos/HPF) respectively. Mean pre- and post- treatment peak eosinophil counts for the Splenda(R) group were 59.5 eos/HPF (range, 20-180 eos/HPF) and 25.5 eos/HPF (range, 0-200 eos/HPF) respectively. The OR of success with Neocate Nutra(R) as compared to Splenda(R) was 6.93 (95% CI: [0.83, 57.91], p-value=0.0728) demonstrating non-inferiority of Neocate Nutra(R).
Conclusion: We demonstrate that OVB mixed with Neocate(R) Nutra is at least as effective as OVB mixed with Splenda(R) at treating children with eosinophilic esophagitis. Neocate Nutra(R) is an innovative, effective, and palatable mixing agent to create a viscous budesonide slurry for families who prefer not to use the standard recipe with Splenda(R).
(C) 2014 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology,