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 evaluate the prevalence of gastroesophageal reflux disease (GERD) symptoms in pediatric patients with cystic fibrosis using the Gastroesophageal Symptom Assessment Scale (GSAS) and the impact of stopping anti-GERD therapy on the GERD symptoms reported.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 18
Healthy Volunteers: f
View:
• Children 2-18 years of age with a confirmed CF diagnosis by either a positive sweat test or 2 disease causing CFTR mutations.
• Signed consent
Locations
United States
North Carolina
Duke University Hospital
RECRUITING
Durham
Contact Information
Primary
Yara Salameh, MF
yara.salameh@duke.edu
919-684-8111
Backup
Shatha Yousef, MD
shatha.yousef@duke.edu
Time Frame
Start Date: 2024-10-23
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 20
Treatments
Experimental: Child with cystic fibrosis (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.
No_intervention: Child with cystic fibrosis (CF)
The GSAS will be completed at baseline.
Related Therapeutic Areas
Sponsors
Leads: Duke University
Collaborators: Cystic Fibrosis Foundation