Actively Recruiting
Characteristics of Gastroesophageal Reflux in Children With Cystic Fibrosis
Led by Duke University · Updated on 2025-12-19
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
D
Duke University
Lead Sponsor
C
Cystic Fibrosis Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying gastroesophageal reflux disease (GERD) symptoms in children aged 2 to 18 years who have cystic fibrosis (CF). The study aims to understand how common GERD symptoms are in these pediatric patients using the Gastroesophageal Symptom Assessment Scale (GSAS) and to evaluate the effects of stopping anti-GERD therapy on these symptoms. This research is sponsored by Duke University and seeks to provide insights into GERD management in children with CF. Participants will complete the GSAS questionnaire at the start of the study. Those currently receiving GERD therapy will stop their medication at enrollment, and their symptoms will be reassessed with the GSAS 12 weeks later. Children not on GERD therapy will only complete the GSAS at baseline. The study includes two groups: children with CF on GERD therapy without severe GERD and children with CF not receiving GERD therapy. During the study, children will be monitored for changes in their GSAS scores to assess GERD symptom severity before and after stopping GERD treatment. The main outcomes measured are the change in GSAS scores from baseline to 12 weeks in children who stop GERD medication, as well as average GSAS scores at baseline for children on and off GERD therapy. The total study participation will last at least 12 weeks after the initial assessment for those discontinuing therapy.
CONDITIONS
Brief Title
GERD in Children With Cystic Fibrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children 2-18 years of age with a confirmed cystic fibrosis diagnosis by either a positive sweat test or two disease-causing CFTR mutations
- Signed consent to participate in the study
You will not qualify if you...
- Declining to participate in the study or sign consent
- History of severe GERD diagnosed and documented by a gastroenterologist
- GSAS score greater than 80
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants who are on GERD therapy will discontinue the therapy at enrollment and complete questionnaires at baseline and 12 weeks later to assess symptoms.
2 visits (in-person) at baseline and 12 weeks
Trial Site Locations
Total: 1 location
1
Duke University Hospital
Durham, North Carolina, United States, 27710
Actively Recruiting
Research Team
Y
Yara Salameh, MF
S
Shatha Yousef, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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