GERD in Children With Cystic Fibrosis
Characteristics of Gastroesophageal Reflux in Children With Cystic Fibrosis
1 other identifier
interventional
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2024
CompletedFirst Posted
Study publicly available on registry
September 27, 2024
CompletedStudy Start
First participant enrolled
October 23, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
December 19, 2025
December 1, 2025
1.7 years
September 25, 2024
December 12, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Change from baseline in the mean GSAS score (only if GERD medication discontinued)
The Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS) is a 15-item tool validated in children in assessing gastroesophageal reflux disease-related symptoms. The GSAS ranges from 0 to 490, with a higher score representing worse GERD symptoms, and a score ≥ 15 reflects significant GERD symptoms.
baseline and 12 weeks
Mean GSAS score in children with CF on GERD therapy
GSAS ranges from 0 to 490, with a higher score representing worse GERD symptoms, and a score ≥ 15 reflects significant GERD symptoms. A value of 80 will be used as a maximum cut-off for mild symptoms as this was 2 SD from the mean GSAS for children without baseline GERD.
Baseline
Mean GSAS score in children with CF not on GERD therapy
GSAS ranges from 0 to 490, with a higher score representing worse GERD symptoms, and a score ≥ 15 reflects significant GERD symptoms. A value of 80 will be used as a maximum cut-off for mild symptoms as this was 2 SD from the mean GSAS for children without baseline GERD.
Baseline
Study Arms (2)
Child with cystic fibrosis (CF) on GERD therapy without severe GERD
EXPERIMENTALThe GSAS will be completed at baseline, GERD therapy will be discontinued, and GSAS will be repeated 12 weeks later.
Child with cystic fibrosis (CF)
NO INTERVENTIONThe GSAS will be completed at baseline.
Interventions
GERD therapy will be discontinued at time of enrollment.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Declining to participate in the study or sign consent
- History of severe GERD per gastroenterology diagnosis and documentation
- GSAS score \>80
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- Cystic Fibrosis Foundationcollaborator
Study Sites (1)
Duke University Hospital
Durham, North Carolina, 27710, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Shatha Yousef
Duke University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2024
First Posted
September 27, 2024
Study Start
October 23, 2024
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
December 19, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share