Phase 2
N=19
Proton Pump Inhibitors (PPI) and Fat Absorption in Cystic Fibrosis (CF) and Exocrine Pancreatic Insufficiency (EPI)
Pancreatic Insufficiency · Cystic Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT03551691 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Coefficient of Fat Absorption — 80; 77 % fat absorption
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Omeprazole 20mg Capsule (Drug); Placebo oral capsule (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Children's Hospital of Philadelphia
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Coefficient of Fat Absorption |
80; 77 | — |
| SECONDARY Duodenal pH |
6.03; 5.38 | — |
| SECONDARY Fat Absorption Via Malabsorption Blood Test |
7.3; 9.6 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03551691). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.