GERD in Children With Cystic Fibrosis

Launched by DUKE UNIVERSITY · Sep 25, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at children with Cystic Fibrosis (CF) who also have a condition called gastroesophageal reflux disease (GERD), which can cause symptoms like heartburn and discomfort. The study aims to understand how these symptoms change when children stop taking their GERD medications after being treated for a while. Researchers will use surveys to gather information about the children’s reflux symptoms during this time.

To participate in the study, children need to be between 6 and 17 years old and have a confirmed diagnosis of Cystic Fibrosis. They should also have been on a stable dose of GERD medication for at least three months. It’s important for parents to know that children who have severe GERD or are not willing to stop their medications cannot take part in this trial. If eligible, participants will be asked to stop their GERD treatment and complete surveys about their symptoms, helping doctors learn more about managing GERD in children with Cystic Fibrosis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Children 6-17 years of age with a confirmed CF diagnosis by either a positive sweat test or 2 disease causing CFTR mutations.
• • GERD medications documented at visit 1
• • Stable GERD medication dose for 3 months
• • Pediatric GERD Symptom Assessment Score \<80
• • Signed consent
• Exclusion Criteria:
• • Declining to participate in the study or sign consent
• • Unwillingness to stop GERD therapy
• • History of severe GERD per gastroenterology diagnosis and documentation
• • GSAS score \>80