CFDB - Cystic Fibrosis DataBase

primary studies published RCT

Effectiveness and safety of small vs. large doses of enteric coated pancreatic enzymes in reducing steatorrhea in children with cystic fibrosis: a prospective randomized study.

Study design (if review, criteria of inclusion for studies)

randomized crossover study

Participants

9 nourished children with CF

Interventions

patient's usual dose versus 1/4 usual dose of EC enzymes in two consecutive 7 day treatment periods within each child.

Outcome measures

serum urate (SU) and urinary uric acid (UUA), fecal fat and stool nitrogen

Main results

Large doses of EC enzymes reduced steatorrhea and increased SU and UUA. SU was normal with both treatments and UUA was normal, i.e., 17 of 18 values were between the 10th and 95th percentiles for healthy children eating a normal diet. When fat excretion was greater than 10% with small doses of EC enzymes, large doses resulted in reduced fat excretion and normal UUA.

Authors' conclusions

These data suggest that large doses of EC enzymes reduce steatorrhea and are safe in patients who have malabsorbtion with small doses.

Keywords: Child; Enteric-Coated; pharmacological_intervention; Pancreatic Enzyme Replacement Therapy; Proteins; Supplementation; Pancreas insufficiency; Pancreatic Diseases; Gastrointestinal Diseases; Malabsorption; Nutrition Disorders; Gastrointestinal Agents;