Status:
COMPLETED
Multicenter Study of Patient-reported Gastrointestinal Symptoms in People With Cystic Fibrosis
Lead Sponsor:
Chris Goss
Collaborating Sponsors:
Emory University
University of North Carolina, Charlotte
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
2+ years
Brief Summary
This is a prospective, multicenter, observational study designed to collect gastrointestinal related data in patients with Cystic Fibrosis (CF).
Detailed Description
There are currently no large, multicenter prospective clinical trials examining management of constipation or other gastrointestinal (GI) symptoms in people with cystic fibrosis (CF). Current recommen...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 17 2019
Estimated Enrollment :
402 Patients enrolled
Trial Details
Trial ID
NCT03801993
Start Date
May 1 2019
End Date
September 17 2019
Last Update
October 15 2024
Active Locations (26)
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1
Stanford University Medical Center
Palo Alto, California, United States, 94304
2
Central Connecticut Cystic Fibrosis Center
Hartford, Connecticut, United States, 06106
3
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20816
4
Nemours Children's Clinic - Pensacola
Pensacola, Florida, United States, 32514