Clinical trial NCT03551691: Proton Pump Inhibitors (PPI) and Fat Absorption in Cystic Fibrosis (CF) and Exocrine Pancreatic Insufficiency (EPI)
Official title: Proton Pump Inhibitors (PPI) and Fat Absorption in Subjects With Cystic Fibrosis (CF) and Exocrine Pancreatic Insufficiency (EPI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Insufficiency
Cystic Fibrosis
Keywords: fat absorption
pancreatic enzyme
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Chiesi USA, Inc.
First posted: 2018-06-11
Enrollment: 19
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Coefficient of Fat Absorption
timeFrame: After 28 days of treatment or placebo
Secondary outcomes:
measure: Duodenal pH
timeFrame: After 28 days of treatment or placebo
measure: Fat Absorption Via Malabsorption Blood Test
timeFrame: After 28 days of treatment or placebo
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Virginia A Stallings, MD
role: PRINCIPAL_INVESTIGATOR
References:
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