GERD in Children With Cystic Fibrosis

Not Applicable

Recruiting

• Conditions: GERD in Children; Cystic Fibrosis in Children
• Interventions: Other: Discontinuation of GERD therapy

• Registration Number: NCT06617013
• Lead Sponsor: Duke University

Brief Summary

The purpose of this study is to use a survey to measure reflux symptoms in patients with Cystic Fibrosis who are on reflux treatment, and to monitor their symptoms after stopping the reflux treatment.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-25
• Study First Submitted QC: 2024-09-25
• Study First Posted: 2024-09-27
• Study Start: 2024-10-23
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-25
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Child with CF on GERD therapy without severe GERD	Discontinuation of GERD therapy	The GSAS will be completed at baseline, GERD therapy will be discontinued, and GSAS will be repeated 12 weeks later.

Primary Outcome Measures

Name	Time	Method
Change from baseline in the mean GSAS score	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.
Mean GSAS score in children with CF on GERD therapy	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.

Trial Locations

Locations (1)

Duke University Hospital; 🇺🇸 Durham, North Carolina, United States