Enteric-coated pancreatic enzyme with bicarbonate is equal to standard enteric-coated enzyme in treating malabsorption in cystic fibrosis

J Pediatr Gastroenterol Nutr. 2006 Mar;42(3):256-61. doi: 10.1097/01.mpg.0000189356.93784.01.


Objectives: To compare the efficacy of an enteric-coated buffered pancreatic enzyme (EC buffered PE) containing 1.5 mEq of bicarbonate per capsule with a conventional enteric-coated enzyme (EC-PE) capsule in cystic fibrosis patients with signs or symptoms of moderate to severe malabsorption.

Methods: In a double-blind crossover study, subjects were randomly assigned to two consecutive, 2-week phases using an EC buffered PE product and conventional EC-PE product. Seventy-two hour stool collections from each phase were analyzed for energy, fat, and nitrogen content and expressed as percent of estimated intake.

Results: Twenty-one patients with cystic fibrosis and pancreatic insufficiency (14 female, mean age 20.6 +/- 11.5 years, range 8.8-41.9) completed the study. There was no significant difference in percent malabsorption of energy (19.4% vs. 19.0%), fat (20.7% vs. 20.2%), or nitrogen (10.4% vs. 10.7%) between the EC buffered PE product and the conventional EC-PE product. However, patients taking the EC buffered PE product received less enzyme based on actual enzyme activity measured in vitro (3,468 +/- 1,434 U lipase/g fat vs. 3,978 +/- 1,474 U lipase/g fat, P < 0.02).

Conclusions: In the doses used, nutrient absorption of patients taking EC buffered PE preparation offers no advantage over a conventional EC-PE preparation.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Bicarbonates / pharmacology
  • Child
  • Cross-Over Studies
  • Cystic Fibrosis / complications*
  • Double-Blind Method
  • Exocrine Pancreatic Insufficiency / drug therapy*
  • Exocrine Pancreatic Insufficiency / enzymology
  • Feces / chemistry*
  • Female
  • Gastrointestinal Agents / therapeutic use*
  • Humans
  • Lipid Metabolism
  • Malabsorption Syndromes / drug therapy*
  • Malabsorption Syndromes / enzymology
  • Male
  • Nitrogen / analysis
  • Pancrelipase / therapeutic use*
  • Tablets, Enteric-Coated
  • Treatment Outcome


  • Bicarbonates
  • Gastrointestinal Agents
  • Tablets, Enteric-Coated
  • Pancrelipase
  • Nitrogen