Ignite Creation Date:
2024-05-06 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 12:47 PM
Study NCT ID:
NCT03551691
Status:
COMPLETED
Last Update Posted:
2024-04-30
First Post:
2018-05-29
Brief Title:
Proton Pump Inhibitors PPI and Fat Absorption in Cystic Fibrosis CF and Exocrine Pancreatic Insufficiency EPI
Sponsor:
Childrens Hospital of Philadelphia
Organization:
Childrens Hospital of Philadelphia
Study Overview
Official Title:
Proton Pump Inhibitors PPI and Fat Absorption in Subjects With Cystic Fibrosis CF and Exocrine Pancreatic Insufficiency EPI
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None