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:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2025-12-24 @ 9:26 PM
NCT ID:
NCT00095732
Eligibility Criteria:
Inclusion Criteria:
* Pancreatic insufficiency (PI) documented by fecal elastase \<100 mcg/gram measured at screening
* Diagnosis of CF based upon the following criteria:
* two clinical features consistent with CF AND
* either genotype with two identifiable mutations consistent with CF OR
* sweat chloride \> 60 mEq/L by quantitative pilocarpine iontophoresis
* Forced Expiratory Volume Over One Second (FEV1) ≥30% predicted
* Clinically stable with no evidence of acute upper or lower respiratory tract infection
Exclusion Criteria:
* Pregnancy, breastfeeding or of childbearing potential and/or not willing to use accepted methods of birth control during enrollment in the study
* History of fibrosing colonopathy
* History of liver transplant or lung transplant
* Unable to discontinue enteral tube feedings during the study
* Subject weight \<40 kg
* Known hypersensitivity to food additives
* Participation in an investigational study of a drug, biologic, or device not currently approved for marketing within 30 days prior to screening
* Unable to discontinue the use of pancreatic enzymes for a 72-hour period or any other condition that the investigator believes would interfere with the intent of this study or would make study participation not in the best interest of the subject
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Study:
NCT00095732
Study Brief:
Protocol Section:
NCT00095732