A Randomized Controlled Comparison of Esophageal Clearance Times of Oral Budesonide Preparations

Dig Dis Sci. 2016 Jun;61(6):1582-90. doi: 10.1007/s10620-015-3990-4. Epub 2016 Feb 26.

Abstract

Background: Topical steroids prepared as oral viscous slurries have become common in the treatment of eosinophilic esophagitis. Esophageal mucosal contact time correlates with clinical and histologic improvement.

Aim: To compare the mucosal contact time of alternative oral viscous budesonide (OVB) slurries with the conventional sucralose OVB.

Methods: A blinded randomized crossover trial investigating esophageal clearance of three OVB slurry preparations was done on healthy adults. Honey and xanthan gum OVB slurries were compared with standard sucralose OVB in 24 randomly assigned subjects. Each subject ingested the sucralose OVB and either the honey or xanthan gum OVB slurries. The esophageal clearance of each slurry was evaluated as an area under the curve (AUC) using 1 millicurie of technetium-99m-sulfur colloid (Tc99) co-administered in each OVB preparation using nuclear scintigraphy. A standardized taste survey was also administered.

Results: Xanthan gum had greater mucosal contact time compared to sucralose as measured by a higher AUC at 3 min (P = 0.002), while honey showed no significant difference in esophageal clearance relative to sucralose. Taste scores were significantly higher in the honey group, while scores for xanthan gum were no different from standard sucralose.

Conclusion: OVB slurries utilizing xanthan gum may be a superior alternative to a sucralose-based slurry due to its increased mucosal contact time and similar taste tolerance. Honey may be a suitable alternative as well, due to its similar contact time and favorable taste.

Keywords: Budesonide; Eosinophilic esophagitis; Honey; OVB; Viscous budesonide slurry; Xanthan gum.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Adult
  • Area Under Curve
  • Budesonide / administration & dosage*
  • Budesonide / blood
  • Budesonide / pharmacokinetics*
  • Cross-Over Studies
  • Female
  • Honey / analysis
  • Humans
  • Male
  • Middle Aged
  • Polysaccharides, Bacterial / chemistry
  • Sucrose / analogs & derivatives
  • Young Adult

Substances

  • Polysaccharides, Bacterial
  • Budesonide
  • Sucrose
  • trichlorosucrose
  • xanthan gum