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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 January 2024 |
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Main ID: |
NCT03551691 |
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Date of registration:
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29/05/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Proton Pump Inhibitors (PPI) and Fat Absorption in Cystic Fibrosis (CF) and Exocrine Pancreatic Insufficiency (EPI)
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Scientific title:
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Proton Pump Inhibitors (PPI) and Fat Absorption in Subjects With Cystic Fibrosis (CF) and Exocrine Pancreatic Insufficiency (EPI) |
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Date of first enrolment:
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August 7, 2018 |
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Target sample size:
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19 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03551691 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Virginia A Stallings, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Children's Hospital of Philadelphia |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Pancreatic Insufficiency
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Intervention(s)
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Drug: Omeprazole 40mg Capsule
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Drug: Placebo oral capsule
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Primary Outcome(s)
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Coefficient of fat absorption
[Time Frame: After 28 days of treatment or placebo]
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Secondary Outcome(s)
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Duodenal pH
[Time Frame: After 28 days of treatment or placebo]
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Fat absorption via Malabsorption Blood Test
[Time Frame: After 28 days of treatment or placebo]
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Secondary ID(s)
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17-014666
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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