Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT01430234
Eligibility Criteria:
Inclusion Criteria:
* age ≥ 18 years.
* EPI caused by CP.
* Treated with enzyme therapy (≤ 6 capsules of 25.000 FIP-E units of lipase per day).
* Fecal elastase \< 0.200 mg/g
* fecal fat-absorption \< 85% without using enzymes.
Exclusion Criteria:
* Subjects who are unwilling or unable to understand and participate in the study and/or sign the informed consent.
* Any known gastro-intestinal disease or major gastrointestinal or pancreatic surgery that could potentially affect the intestinal absorption or metabolism of fat
* Gastroparesis of any aetiology
* Hypersensitivity to pork protein
* Acute pancreatitis
* Limited life-expectancy of ≤ 6 months
* Malignancy of the pancreas
* Pregnancy/lactation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT01430234
Study Brief:
Protocol Section:
NCT01430234