GERD in Children With Cystic Fibrosis

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT06617013
Status
Recruiting
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Conditions

  • Cystic Fibrosis in Children
  • GERD in Children

Eligibility Criteria

Sex
ALL
Age
2 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Discontinuation of GERD therapy — OTHER
    GERD therapy will be discontinued at time of enrollment.

Study Details

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.

Key Dates

Start date
Oct 23, 2024
Status verified
Dec 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Change from baseline in the mean GSAS score (only if GERD medication discontinued) [ Time Frame: baseline and 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University HospitalDurhamNorth Carolina27710
Yara Salameh, MF
[email protected]
919-684-8111

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By research site
Duke University Hospital· Durham, NC

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