Lipid Formulation to Increase the Bioavailability of Fatty Acids in Cystic Fibrosis (CF) Patients

Inclusion criteria

• Previously diagnosed CF according to established criteria (diagnosis of CF will be based on either two positive sweat chloride tests of >60 mEq/L or the identification of two detectable mutations associated with CF)
• Exocrine pancreatic insufficiency defined by pathological fecal elastase (<15µg/g) found in the Medical History of the patient
• Informed consent letter signed and dated by their parents or legal guardians before inclusion in the study, and assent signed and dated by the child if he or she is ≥ 14 years old

Exclusion criteria

• Any change (initiation, change in type of drug, dose modification, schedule modification, interruption, discontinuation, or re-initiation) in a chronic treatment/prophylaxis regimen for CF or for CF-related conditions within 4 weeks prior to baseline
• Exposure to another investigational drug or dietary supplements and enteral nutrition containing EPA and docosahexaenoic acid (DHA), Fish or the use of any other supplement containing fish oil within 4 weeks prior to baseline.
• Treatment with intravenous antibiotics within 4 weeks prior to baseline
• Newly started oral antibiotic treatment within 4 weeks prior to Baseline
• History of solid organ or hematological transplantation
• Ongoing immunosuppressive therapy (other than corticosteroids) within 3 weeks prior to baseline
• Major complications of lung disease (including massive hemoptysis, pneumothorax, or pleural effusion) within 8 weeks prior to baseline
• Evidence of pulmonary exacerbation or acute upper or lower respiratory tract infection (including viral illnesses) within 3 weeks prior to baseline
• Having donated blood or had a transfusion of blood/blood products during the trial and 3 months prior to screening or expected to do so during the study
• Any bleeding disorders at screening
• Patient who cannot be expected to comply with the study procedures.
• Currently participating or having participated in another clinical trial within 8 weeks prior to baseline.
• Any known food allergy
• Incapacity to swallow capsules