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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03551691
Date of registration: 29/05/2018
Prospective Registration: Yes
Primary sponsor: Children's Hospital of Philadelphia
Public title: PPIs and Fat Absorption in CF and EPI
Scientific title: Proton Pump Inhibitors and Fat Absorption in Subjects With Cystic Fibrosis and Pancreatic Insufficiency
Date of first enrolment: August 7, 2018
Target sample size: 24
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT03551691
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 2
Countries of recruitment
United States
Contacts
Name:     Jefferson N Brownell, MD
Address: 
Telephone: 267-425-1628
Email: brownellj@email.chop.edu
Affiliation: 
Name:     Jefferson N Brownell, MD
Address: 
Telephone: 2674251628
Email: brownellj@email.chop.edu
Affiliation: 
Name:     Virginia A Stallings, MD
Address: 
Telephone:
Email:
Affiliation:  Children's Hospital of Philadelphia
Key inclusion & exclusion 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



Age minimum: 12 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Cystic Fibrosis
Pancreatic Insufficiency
Intervention(s)
Drug: Omeprazole 40mg Capsule
Drug: Placebo oral capsule
Primary Outcome(s)
Coefficient of fat absorption [Time Frame: After 28 days of treatment or placebo]
Secondary Outcome(s)
Duodenal pH [Time Frame: After 28 days of treatment or placebo]
Fat absorption via Malabsorption Blood Test [Time Frame: After 28 days of treatment or placebo]
Secondary ID(s)
17-014666
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Chiesi Farmaceutici S.p.A.
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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