GERD in Children With Cystic Fibrosis

NCT ID: NCT06617013

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-23

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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GERD in Children Cystic Fibrosis in Children

Study Design

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Allocation Method

NA

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Discontinuation of GERD therapy

Intervention Type OTHER

GERD therapy will be discontinued at time of enrollment.

Child with cystic fibrosis (CF)

The GSAS will be completed at baseline.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Discontinuation of GERD therapy

GERD therapy will be discontinued at time of enrollment.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cystic Fibrosis Foundation

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shatha Yousef

Role: PRINCIPAL_INVESTIGATOR

Duke University Hospital

Locations

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Duke University Hospital

Durham, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Yara Salameh, MF

Role: CONTACT

Phone: 919-684-8111

Email: [email protected]

Shatha Yousef, MD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Yara Salameh, MF

Role: primary

Other Identifiers

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PRO00115374

Identifier Type: -

Identifier Source: org_study_id