Multicenter Study of Patient-reported Gastrointestinal Symptoms in People With Cystic Fibrosis

Inclusion Criteria

• All genders ≥ 2 years of age at time of consent
• Documentation of a Cystic Fibrosis (CF) diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria:
• Sweat chloride equal to or greater than 60 milliequivalent (mEq)/liter by quantitative pilocarpine iontophoresis test (QPIT)
• Two well-characterized mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene
• Abnormal nasal potential difference (NPD) (change in NPD in response to a low chloride solution and isoproterenol of less than -5 mV)
• Enrolled in the Cystic Fibrosis Foundation Patient Registry (subjects may enroll in the Registry at Enrollment Visit if not previously enrolled)
• Written informed consent (and assent when applicable) obtained from subject or subject's legal representative
• Willing to complete questionnaires on mobile device
• Able to use the Medidata Patient Cloud mobile application for completing the questionnaires

Exclusion Criteria

• Presence of a condition or abnormality that, in the opinion of the Investigator, would complicate interpretation of study outcome data or interfere with achieving the study objectives
• Presence of a pulmonary exacerbation at the Enrollment Visit
• Hospitalization for distal intestinal obstruction syndrome (DIOS) within the 28 days prior to the Enrollment Visit
• Current gastrointestinal (GI) or abdominal/pelvic malignancy
• Abdominal or pelvic surgery within the 28 days prior to the Enrollment Visit
• At the time of the Enrollment Visit, planned abdominal or pelvic surgery or bowel cleanout in the 28 days after the Enrollment Visit
• Initiation of new CFTR modulator therapy within the 4 weeks prior to the Enrollment Visit
• Intent to initiate new CFTR modulator therapy within 28 days of the Enrollment Visit