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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 : July 28, 2021
Sponsor:
Collaborator:
Chiesi Farmaceutici S.p.A.
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pancreatic Insufficiency Cystic Fibrosis Drug: Omeprazole 40mg Capsule Drug: Placebo oral capsule Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Coefficient of fat absorption [ Time Frame: After 28 days of treatment or placebo ]
    Gold standard measurement of fat malabsorption


Secondary Outcome Measures :
  1. Duodenal pH [ Time Frame: After 28 days of treatment or placebo ]
    Change in duodenal pH as measured by the SmartPill

  2. Fat absorption via Malabsorption Blood Test [ Time Frame: After 28 days of treatment or placebo ]
    Measurement of serum pentadecanoic acid and heptadecanoic acid


Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Jefferson N Brownell, MD 2674251628 brownellj@chop.edu
Contact: Joan I Schall, PhD 2674251632 schall@chop.edu

Locations
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United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19146
Contact: Jefferson N Brownell, MD    267-425-1628    brownellj@chop.edu   
Contact: Joan I Schall, PhD    267-425-1632    schall@chop.edu   
Sponsors and Collaborators
Children's Hospital of Philadelphia
Chiesi Farmaceutici S.p.A.
Investigators
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Principal Investigator: Virginia A Stallings, MD Children's Hospital of Philadelphia
More Information
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Publications:

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Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT03551691    
Other Study ID Numbers: 17-014666
First Posted: June 11, 2018    Key Record Dates
Last Update Posted: July 28, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported will be shared upon request, after deidentification.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: The data will be available immediately upon publication.
Access Criteria: Contact brownellj@email.chop.edu. Requestors will need to sign a data access agreement.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Children's Hospital of Philadelphia:
fat absorption
pancreatic enzyme
Additional relevant MeSH terms:
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Cystic Fibrosis
Exocrine Pancreatic Insufficiency
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
 Genetic Diseases, Inborn
Infant, Newborn, Diseases
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action