Recruiting

Observational Study

Sponsor:

Duke University

Code:

NCT06617013

Conditions

GERD in Children

Cystic Fibrosis in Children

Eligibility Criteria

Sex: All

Age: 2 - 18

Healthy Volunteers: Not accepted

Interventions

Discontinuation of GERD therapy

Study Details

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.

Conditions

GERD in Children

Cystic Fibrosis in Children

Study ID

NCT06617013

Start date

Oct 23, 2024

Status verified date

Dec, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 18

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Discontinuation of GERD therapy

GERD therapy will be discontinued at time of enrollment.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Yara Salameh, MF

919-684-8111yara.salameh@duke.edu

Shatha Yousef, MD

shatha.yousef@duke.edu

Locations

Duke University Hospital

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Yara Salameh, MF

919-684-8111yara.salameh@duke.edu

More Information

Sponsor

Duke University

Last update posted

Dec 19, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2025-12-19.