Characteristics of Gastroesophageal Reflux in Children With Cystic Fibrosis
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The purpose of this study is to use a survey to measure reflux symptoms in patients with Cystic Fibrosis who are on reflux treatment, and to monitor their symptoms after stopping the reflux treatment.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 17
Healthy Volunteers: f
View:
• Children 6-17 years of age with a confirmed CF diagnosis by either a positive sweat test or 2 disease causing CFTR mutations.
• GERD medications documented at visit 1
• Stable GERD medication dose for 3 months
• Pediatric GERD Symptom Assessment Score \<80
• Signed consent
Locations
United States
North Carolina
Duke University Hospital
RECRUITING
Durham
Contact Information
Primary
Shannon P Williams, DO
shannon.williams@duke.edu
678-837-8156
Backup
Shatha Yousef, MD
shatha.yousef@duke.edu
Time Frame
Start Date: 2024-10-23
Estimated Completion Date: 2025-04-30
Participants
Target number of participants: 20
Treatments
Experimental: Child with CF on GERD therapy without severe GERD
The GSAS will be completed at baseline, GERD therapy will be discontinued, and GSAS will be repeated 12 weeks later.
Related Therapeutic Areas
Sponsors
Leads: Duke University
Collaborators: Cystic Fibrosis Foundation