Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06617013

GERD in Children With Cystic Fibrosis

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

GERD in Children Cystic Fibrosis in Children

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Hospital

Durham, North Carolina, 27710, United States

Location status: Recruiting

Location contact

Yara Salameh, MF

CONTACT

[email protected]

919-684-8111

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Discontinuation of GERD therapy

Other

GERD therapy will be discontinued at time of enrollment.

Primary outcomes

  1. Change from baseline in the mean GSAS score (only if GERD medication discontinued)

    Time frame: baseline and 12 weeks

    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.

  2. Mean GSAS score in children with CF on GERD therapy

    Time frame: Baseline

    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.

  3. Mean GSAS score in children with CF not on GERD therapy

    Time frame: Baseline

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Shatha Yousef, MD

CONTACT

[email protected]

Yara Salameh, MF

CONTACT

[email protected]

919-684-8111

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Cystic Fibrosis Foundation

Registry information

Official study title

Characteristics of Gastroesophageal Reflux in Children With Cystic Fibrosis

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 27, 2024
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.