Proton Pump Inhibitors (PPI) and Fat Absorption in Cystic Fibrosis (CF) and Exocrine Pancreatic Insufficiency (EPI)

Children's Hospital of Philadelphia (CHOP)

Status and phase

Completed

Phase 2

Conditions

Pancreatic Insufficiency

Cystic Fibrosis

Treatments

Drug: Placebo oral capsule

Drug: Omeprazole 20mg Capsule

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03551691

17-014666

Details and patient eligibility

About

This is a clinical trial with a cross over design investigating the effect of the proton pump inhibitor omeprazole on fat malabsorption in subjects with cystic fibrosis and pancreatic insufficiency. Participants will be randomized to receive either omeprazole or placebo for 28 days, then cross over and receive omeprazole or placebo for another 28 days. Markers of fat absorption will be measured after each treatment course.

Full description

Fat malabsorption contributes to poor nutritional status in people with cystic fibrosis (CF) and exocrine pancreatic insufficiency (EPI). Prescribing gastric acid-reducing agents such as proton pump inhibitors (PPIs) and histamine receptor antagonists (H2RAs) as an adjunct to pancreatic enzyme replacement therapy (PERT) to improve PERT efficacy and dietary fat absorption has become accepted clinical practice in CF, despite limited evidence to support the practice. Establishing the efficacy and true health benefit of acid suppression for nutritional status and outcomes in CF is particularly important in light of potential health risks and cost associated with long-term or even lifetime use of these medications.

This study aims to characterize changes in fat malabsorption using the coefficient of fat absorption (CFA) as the primary endpoint in subjects who are on and off acid suppression with a PPI in addition to PERT. Additionally, the SmartPill® will be used to evaluate duodenal power of hydrogen (pH) while on and off acid suppression, and the malabsorption blood test (MBT) will be used to characterize changes in fat absorption. Associations will be explored between changes in nutritional status (weight, height, BMI), clinical GI symptoms, and quality of life in subjects treated with PPI vs. placebo.

Enrollment

19 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Cystic fibrosis and pancreatic insufficiency (Fecal elastase <200 ug/g stool)
Age ≥12 years
In usual state of good health
Willing to participate in a four-month study with three visits

Exclusion criteria

Forced expiratory vital capacity at one second (FEV1) <40% predicted
Pregnancy or breast feeding
Other illness affecting growth or nutritional status
Unwillingness to continue their clinically established PERT dose for the duration of the study
Use of other medication that affects dietary fat absorption
Allergy to soy products
Allergy to safflower products
For subjects ≥18 years, celiac disease or allergy to gluten