GERD in Children With Cystic Fibrosis

Duke University

Status: Enrolling

Conditions: GERD in Children; Cystic Fibrosis in Children

Treatments: Other: Discontinuation of GERD therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06617013

PRO00115374

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Child with cystic fibrosis (CF) on GERD therapy without severe GERD

Experimental group

Description:

The GSAS will be completed at baseline, GERD therapy will be discontinued, and GSAS will be repeated 12 weeks later.

Treatment:

Other: Discontinuation of GERD therapy

Child with cystic fibrosis (CF)

No Intervention group

Description:

The GSAS will be completed at baseline.