PPIs and Fat Absorption in CF and EPI

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital of Philadelphia
• Collaborators: Chiesi Farmaceutici S.p.A.; Chiesi USA
• Treatments: Omeprazole

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