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Recruiting NCT06617013

GERD in Children With Cystic Fibrosis

No phase Interventional GERD in Children Cystic Fibrosis in Children

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Discontinuation of GERD therapy.
Who it may be relevant to
Registry conditions: GERD in Children, Cystic Fibrosis in Children. Basic parameters: 2 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Characteristics of Gastroesophageal Reflux in Children With Cystic Fibrosis

Overview

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.

Interventions

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

Primary outcome measures

  • Change from baseline in the mean GSAS score (only if GERD medication discontinued) [Time frame: baseline and 12 weeks]
  • Mean GSAS score in children with CF on GERD therapy [Time frame: Baseline]
  • Mean GSAS score in children with CF not on GERD therapy [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • Declining to participate in the study or sign consent
  • History of severe GERD per gastroenterology diagnosis and documentation
  • GSAS score >80

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Duke University Hospital — Durham

Identifiers

NCT: NCT06617013 · PRO00115374

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗