Assessment of a PERT-free Nutritional Therapeutic Delivery System for Cystic Fibrosis

Exclusion Criteria

• •Evidence of cardiovascular, respiratory (except underlying disease), urogenital, gastrointestinal/hepatic (except underlying disease), hematologic/immunologic, head, ears, eyes, nose, throat, dermatologic/connective tissue, musculoskeletal, metabolic/nutritional (except underlying disease), endocrine (except controlled diabetes mellitus), neurologic/psychiatric, milk, nut or soy allergies, recent major surgery, or other relevant diseases as revealed by history, physical examination and/or laboratory assessments, which could limit participation in or completion of the study.
• •History of acute abdomen in the last year.
• •History of fibrosing colonopathy.
• •History of distal intestinal obstruction syndrome (DIOS) within 6 months prior to enrollment.
• •Solid organ transplant or surgery affecting the large bowel other than appendectomy.
• •Small bowel surgery that significantly affected absorptive capacity (e.g. gastrectomy or pancreatectomy).
• •Intestinal inflammatory diseases including chronic diarrheal illness unrelated to pancreatic insufficiency.
• •Celiac disease or Crohn's disease.
• •Receiving enteral tube feeds for ≥50% of daily calorie intake.
• •Pregnancy or lactation.
• •Any type of malignancy involving the digestive tract in the last 5 years.
• •Known allergy to pancreatin or inactive ingredients (excipients) of pancreatin capsules.
• •Suspected non-compliance or non-cooperation.
• •Intake of experimental drugs within 30 days prior to study start.
• •Mental disability or any other lack of fitness, in the Investigator's opinion, to preclude subject's participation in or ability to complete the study.
• •Diagnosis of human immunodeficiency virus in medical history.
• •Listed for lung transplantation or other solid organ transplant or documented forced expiratory volume (FEV) ≤25%.
• •Use of lipid lowering therapy including statins, fibrates, niacin, and proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors that cannot be held at least 14 days prior to Day 1 and through Day 15 of the study.