GERD in Children With Cystic Fibrosis
This study is looking at children with cystic fibrosis (CF) to understand how common gastroesophageal reflux disease (GERD) symptoms are. Researchers will use a survey called the Gastroesophageal Symptom Assessment Scale (GSAS) to measure these symptoms. For some children already taking GERD medicine, this study will look at what happens to their symptoms if they stop taking that medicine. To join, children must be between 2 and 18 years old with a confirmed CF diagnosis. Children with severe GERD or a very high GSAS score cannot participate. The study aims to enroll 20 children, but its current status is unclear.
- Study design
- This is an interventional study planning to enroll 20 participants. It will look at the impact of stopping GERD therapy.
- What's involved
- Participants will have their GERD therapy discontinued at the time of enrollment. Symptoms will be assessed at baseline and 12 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 12 weeks after enrollment.
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GERD in Children With Cystic Fibrosis
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Shatha Yousef · PRINCIPAL_INVESTIGATOR · Duke University Hospital
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- 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 therapyBaseline
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 therapyBaseline
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.