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Proton Pump Inhibitor

Treatment Arm for Pancreatic Insufficiency

Phase 2
Waitlist Available
Led By Virginia A Stallings, MD
Research Sponsored by Children's Hospital of Philadelphia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Cystic fibrosis and pancreatic insufficiency (Fecal elastase <200 ug/g stool)
Age ≥12 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 28 days of treatment or placebo
Awards & highlights

Study Summary

This trial is investigating whether omeprazole can help improve fat absorption in people with cystic fibrosis and pancreatic insufficiency.

Eligible Conditions
  • Pancreatic Insufficiency
  • Cystic Fibrosis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 28 days of treatment or placebo
This trial's timeline: 3 weeks for screening, Varies for treatment, and after 28 days of treatment or placebo for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Coefficient of fat absorption
Secondary outcome measures
Duodenal pH
Fat absorption via Malabsorption Blood Test

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Treatment ArmActive Control1 Intervention
Subjects will take omeprazole 40mg daily for 28 days, then undergo assessments of fat absorption.
Group II: Placebo ArmPlacebo Group1 Intervention
Subjects will take a placebo daily for 28 days, then undergo assessments of fat absorption.

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaLead Sponsor
706 Previous Clinical Trials
8,571,421 Total Patients Enrolled
4 Trials studying Pancreatic Insufficiency
110 Patients Enrolled for Pancreatic Insufficiency
Chiesi USA, Inc.Industry Sponsor
8 Previous Clinical Trials
6,085 Total Patients Enrolled
Virginia A Stallings, MDPrincipal InvestigatorChildren's Hospital of Philadelphia
1 Previous Clinical Trials
58 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~3 spots leftby Mar 2025