Philadelphia, Pennsylvania 19146


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT03551691


Primary Contact:

Principal Investigator
Virginia A Stallings, MD
Children's Hospital of Philadelphia

Jefferson N Brownell, MD
Phone: 2674251628
Email: brownellj@email.chop.edu


Backup Contact:

Email: schall@email.chop.edu
Joan I Schall, PhD
Phone: 2674251632


Location Contact:

Philadelphia, Pennsylvania 19146
United States

Jefferson N Brownell, MD
Phone: 267-425-1628
Email: brownellj@email.chop.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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