Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects ≥ 12 Years of Age With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
Brief Summary: maldigestion of dietary macronutrients (pancreas not producing enough enzymes for digestion of fat, sugars and proteins) in Cystic Fibrosis


Options:
A: Inclusion Criteria:

CF cohort:

Diagnosis of CF determined by

* a sweat chloride of \>60 mEq/L and/or
* detection of 2 disease causing CFTR mutations with evidence of organ involvement.

Healthy controls:

* Age-matched

Exclusion Criteria:

CF cohort:

* Lacking ability to cooperate of patients /their families, respectively

Healthy controls:

* Other diseases causing abdominal symptoms (Inflammatory bowel disease (IBD), alpha 1 antitrypsin deficiency, celiac disease, food allergy, gastroenteritis, etc.)
B: Inclusion Criteria:

* Signed informed consent given by the subject, or the parents, or a legally acceptable representative. If required by the Institutional Review Board/Ethics Committee (IRB/IEC), assent will be given by the subject
* Age ≥ 12 years
* Subjects who are able to swallow capsules with each meal and snacks
* Diagnosis of Cystic Fibrosis (CF) confirmed by two positive chloride sweat tests or gene analysis
* Diagnosis of pancreatic exocrine insufficiency proven by:

  1. Coefficient of fat absorption (CFA) \< 70% without supplementation
  2. or Human fecal elastase \< 50 μg/g stool
* Currently receiving treatment with a commercially available pancreatic enzyme product and on a continuous dose of this product for more than 3 months
* Clinically stable condition without evidence of acute respiratory disease within 1 month of enrollment
* Stable body weight defined as no more than a 5% decline within 3 months of enrolment
* Females of child-bearing potential should agree to continue using a medically acceptable method of birth control throughout the study and for 30 days immediately after the last dose of study drug. Medically acceptable methods of birth control include bilateral tubal ligation or the use of either a contraceptive implant, a contraceptive injection (Depo-Provera™), an intrauterine device, or an oral contraceptive taken within the past 3 months where the subject agrees to continue using during the study or to adopt another birth control method, or a double-barrier method which consists of a combination of any two of the following: diaphragm, cervical cap, condom, or spermicide.

Exclusion Criteria:

* Evidence of cardiovascular, respiratory, urogenital, gastrointestinal/hepatic (except underlying disease), hematologic/immunologic, head, ears, eyes, nose, throat, dermatologic/connective tissue, musculoskeletal, metabolic/nutritional (except underlying disease), endocrine (except diabetes mellitus), neurologic/psychiatric, allergy, 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
* 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)
* Pregnancy or lactation
* Any type of malignancy involving the digestive tract in the last 5 years
* Celiac disease or Crohn's disease
* 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.
C: Inclusion Criteria:

* Females of childbearing potential must be willing to use birth control
* 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
* Clinically stable with no evidence of acute upper or lower respiratory tract infection
* PI determined by fecal elastase \<100 µg/g stool measured at screening
* Able to take pancreatic enzyme supplementation in the form of capsules
* Able to perform the testing (e.g., stool collections) and inpatient stays required for this study, as judged by the Investigator
* Baseline coefficient of fat absorption (CFA) less than or equal to 80%

Exclusion Criteria:

* CFA \>80% at Baseline
* Pregnancy, breastfeeding or of childbearing potential and not willing to use birth control during the study
* History of fibrosing colonopathy
* History of liver transplant, lung transplant or significant surgical resection of the bowel
* Any acute or chronic diarrheal illness unrelated to PI
* Unable to discontinue enteral tube feedings during the study
* Known hypersensitivity to food additives
* Inability to consume the diet required by the study, in the judgment of the Investigator
* Participation in an investigational study of a drug, biologic, or device not currently approved for marketing within 30 days prior to screening
* Abnormal liver function (except for patients with Gilbert Syndrome)
* Signs and/or symptoms of liver cirrhosis, portal hypertension or documented liver disease unrelated to CF
* Distal intestinal obstruction syndrome (DIOS) in the last six months prior to screening
* Unable to discontinue the use of pancreatic enzymes
* Any condition that the Investigator believes would interfere with the intent of this study or would make participation not in the best interest of the patient
* Patient is unlikely to complete the study, as determined by the Investigator
D: Inclusion Criteria:

* Confirmed CF diagnosis by two positive chloride sweat tests or gene analysis
* Confirmed PEI by historical Coefficient of fat Absorption \< 70% without supplementation or current or historical fecal elastase \< 50µg/stool (within the last 12 months)
* Currently receiving treatment with a commercially available pancreatic enzyme product on a stable dose for more than 3 months
* Clinically stable condition without evidence of acute respiratory disease or any other acute condition
* Stable body weight and agrees to abstain from sexual activity

Exclusion Criteria:

* Ileus or acute abdomen
* History of fibrosing colonopathy, celiac disease, gastrectomy, Crohn´s disease and small bowel surgery other than minor resection due to meconium ileus without resulting in malabsorption syndrome
* History of distal ileal obstruction syndrome within 6 months of enrollment
* Use of an immunosuppressive drug
* Any type of malignancy involving the digestive tract in the last 5 years
* Known infection with HIV

Answer: B