Cystic Fibrosis in Children, GERD in Children
Conditions
Brief summary
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.
Interventions
OTHERDiscontinuation of GERD therapy
GERD therapy will be discontinued at time of enrollment.
Sponsors
Cystic Fibrosis Foundation
Duke University
Study design
Allocation
NA
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the mean GSAS score (only if GERD medication discontinued) | 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. |
| Mean GSAS score in children with CF not 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. |
Countries
United States
Contacts
Primary ContactYara Salameh, MF
Backup ContactShatha Yousef, MD
Outcome results
None listed