PPIs and Fat Absorption in CF and EPI
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|ClinicalTrials.gov Identifier: NCT03551691|
Recruitment Status : Recruiting
First Posted : June 11, 2018
Last Update Posted : August 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Insufficiency Cystic Fibrosis||Drug: Omeprazole 40mg Capsule Drug: Placebo oral capsule||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Proton Pump Inhibitors and Fat Absorption in Subjects With Cystic Fibrosis and Pancreatic Insufficiency|
|Actual Study Start Date :||August 7, 2018|
|Estimated Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||June 30, 2020|
Active Comparator: Treatment Arm
Subjects will take omeprazole 40mg daily for 28 days, then undergo assessments of fat absorption.
Drug: Omeprazole 40mg Capsule
Omeprazole 40mg daily for 28 days
Placebo Comparator: Placebo Arm
Subjects will take a placebo daily for 28 days, then undergo assessments of fat absorption.
Drug: Placebo oral capsule
Identically-appearing capsule to omeprazole
- Coefficient of fat absorption [ Time Frame: After 28 days of treatment or placebo ]Gold standard measurement of fat malabsorption
- Duodenal pH [ Time Frame: After 28 days of treatment or placebo ]Change in duodenal pH as measured by the SmartPill
- Fat absorption via Malabsorption Blood Test [ Time Frame: After 28 days of treatment or placebo ]Measurement of serum pentadecanoic acid and heptadecanoic acid
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03551691
|Contact: Jefferson N Brownell, MDfirstname.lastname@example.org|
|Contact: Joan I Schall, PhDemail@example.com|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia||Recruiting|
|Philadelphia, Pennsylvania, United States, 19146|
|Contact: Jefferson N Brownell, MD 267-425-1628 firstname.lastname@example.org|
|Contact: Joan I Schall, PhD 267-425-1632 email@example.com|
|Principal Investigator:||Babette Zemel, PhD||Children's Hospital of Philadelphia|
|Study Director:||Virginia A Stallings, MD||Children's Hospital of Philadelphia|