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

Completed

Conditions studied: Cystic Fibrosis

In brief

This is a prospective, multicenter, observational study designed to collect gastrointestinal related data in patients with Cystic Fibrosis (CF).

Key facts

Study ID

NCT03801993

Run by

Chris Goss

People needed

402

Starts

2019-05-01

Expected to finish

2019-09-17

Last updated by the study team

2024-10-15

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Stanford University Medical Center — Palo Alto, California, United States
• Central Connecticut Cystic Fibrosis Center — Hartford, Connecticut, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Nemours Children's Clinic - Pensacola — Pensacola, Florida, United States
• All Children's Hospital — St. Petersburg, Florida, United States
• Children's Healthcare of Atlanta and Emory University — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• OSF Saint Francis Medical Center — Peoria, Illinois, United States
• Riley Hospital for Children — Indianapolis, Indiana, United States
• University of Kentucky — Lexington, Kentucky, United States
• Maine Medical Center — Portland, Maine, United States
• Boston Children's Hospital, Brigham & Women's Hospital — Boston, Massachusetts, United States
• University of Massachusetts Memorial Health Care — Worcester, Massachusetts, United States
• Helen DeVos Children's Hospital — Grand Rapids, Michigan, United States
• The Minnesota Cystic Fibrosis Center — Minneapolis, Minnesota, United States
• SSM Health Cardinal Glennon Children's Hospital — St Louis, Missouri, United States
• Rutgers - Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States
• Atrium Health Pulmonary Care — Charlotte, North Carolina, United States
• Wake Forest University Baptist Medical Center — Winston-Salem, North Carolina, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Oklahoma Cystic Fibrosis Center — Oklahoma City, Oklahoma, United States
• Oregon Health Sciences University — Portland, Oregon, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• University of Texas Southwestern / Children's Health — Dallas, Texas, United States
• Intermountain Cystic Fibrosis Center — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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