The impact of omeprazole on children with cystic fibrosis (CF) who require high-dose pancreatic en-zymes: A pilot study

Maintaining optimal nutrition is an integral part of routine therapy of cystic fibrosis (CF) patients, as there is an association between nutritional status and severity of pulmonary disease. Since the 1950 s, pancreatic enzyme supplementation has been successfully used to treat the 85% of patients with CF who exhibit pancreatic insufficiency. However, despite pancreatic enzyme supplementation, a significant proportion of patients continue to have malabsorption. Omeprazole, a proton pump inhibitor, may enhance pancreatic enzyme efficacy by significantly reducing gastric acid secretion and by preventing premature enzyme degradation. The purpose of this pilot study was to examine the use of omeprazole in children with CF who were on high dose pancreatic enzymes (>2000 U lipase/kg/meal). Specific aims were to evaluate whether omeprazole: I) is safe, and 2) reduces fat malabsorption. Patients were randomized to receive omeprazole-placebo or placebo-omeprazole in a double-blind, crossover design with two 6-week treatment periods and a I-week washout. Patients 20 kg received 20 mg/day. Data collection included: patient demographics; 72 hour fecal fat; CBC, chemistry profile, prealbumin, H. pylori titer; height, weight, genotype analysis; type, frequency and dose of pancreatic enzymes; 3-day food diary; malabsorption symptom checklist; and self-report re: adherence to omeprazole therapy. Six children were enrolled in the study. One child was dropped because of positive H. pylori. A total of 5 children (5-12 yrs.) were available for analysis. Results of this pilot study indicated that omeprazole was not associated with any adverse effects in the 5 children who were studied. As indicated by 72 hr. fecal fat analyses, in 3/5 children malabsorption decreased on omeprazole, while in 2/5, malabsorption increased. There were no significant changes over the course of treatments in subject weight, height, or prealbumin levels. Further study, using additional subjects is recommended to determine whether omeprazole can decrease malabsorption and to validate its safety in this population. Supported by Astra Pharmaceuticals.