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PPIs and Fat Absorption in CF and EPI

Sponsor
Children's Hospital of Philadelphia (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03551691
Collaborator
Chiesi USA, Inc. (Industry)
16
Enrollment
1
Location
2
Arms
46.8
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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
  • 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

Study Type:
Interventional
Actual Enrollment :
16 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 :
Aug 7, 2018
Actual Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

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

Primary Outcome Measures

  1. Coefficient of fat absorption [After 28 days of treatment or placebo]

    Gold standard measurement of fat malabsorption

Secondary Outcome Measures

  1. Duodenal pH [After 28 days of treatment or placebo]

    Change in duodenal pH as measured by the SmartPill

  2. Fat absorption via Malabsorption Blood Test [After 28 days of treatment or placebo]

    Measurement of serum pentadecanoic acid and heptadecanoic acid

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Children's Hospital of Philadelphia Philadelphia Pennsylvania United States 19146

Sponsors and Collaborators

  • Children's Hospital of Philadelphia
  • Chiesi USA, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT03551691
Other Study ID Numbers:
  • 17-014666
First Posted:
Jun 11, 2018
Last Update Posted:
Apr 12, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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:
Cystic Fibrosis
Exocrine Pancreatic Insufficiency
Fibrosis
Omeprazole

Study Results

No Results Posted as of Apr 12, 2022