Health TrialsbyHealthPanel

GERD in Children With Cystic Fibrosis

ConditionsGERD in ChildrenCystic Fibrosis in Children
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-18
SponsorDuke University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Declining to participate in the study or sign consent

History of severe GERD per gastroenterology diagnosis and documentation

GSAS score >80

Trial design

Design model

Parallel

Treatments tested in this trial

  • Discontinuation of GERD therapy

    Other intervention

    GERD therapy will be discontinued at time of enrollment.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Child with cystic fibrosis (CF) on GERD therapy without severe GERDExperimental treatment 1 intervention
Group B: Child with cystic fibrosis (CF)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

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.

Time frame
baseline and 12 weeks
2

Mean GSAS score in children with CF on GERD therapy

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.

Time frame
Baseline
3

Mean GSAS score in children with CF not on GERD therapy

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.

Time frame
Baseline

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duke University

Lead sponsor

Cystic Fibrosis Foundation

Collaborator

Source ClinicalTrials.gov
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