RecruitingNot Applicable

GERD in Children With Cystic Fibrosis

United States20 participantsStarted 2024-10-23

Plain-language 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.

Who can participate

Age range2 Years – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: baseline and 12 weeks

Mean GSAS score in children with CF on GERD therapy

Timeframe: Baseline

Mean GSAS score in children with CF not on GERD therapy

Timeframe: Baseline

Trial details

NCT IDNCT06617013

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-30

Contact for this trial

Yara Salameh, MF

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

View on ClinicalTrials.gov More GERD in Children trials