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Stopping GERD Therapy for Children with Cystic Fibrosis

N/A
Waitlist Available
Led By Shatha Yousef
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pediatric GERD Symptom Assessment Score <80
GERD medications documented at visit 1
Must not have
Declining to participate in the study or sign consent
History of severe GERD per gastroenterology diagnosis and documentation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 12 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to use a survey to measure reflux symptoms in Cystic Fibrosis patients who are on reflux treatment, and to track their symptoms after they stop the treatment.

Who is the study for?
This trial is for children with Cystic Fibrosis who are currently receiving treatment for Gastroesophageal Reflux Disease (GERD). The study aims to include those who can provide symptom feedback via a survey.
What is being tested?
The study focuses on understanding the impact of stopping GERD therapy in children with Cystic Fibrosis. It involves monitoring changes in reflux symptoms through patient surveys after discontinuing treatment.
What are the potential side effects?
Since this trial involves discontinuing existing GERD therapy, potential side effects may include an increase in acid reflux symptoms such as heartburn, regurgitation, and discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My child's GERD symptoms score is below 80.
Select...
I am currently taking medication for acid reflux.
Select...
I am between 6-17 years old and have a confirmed diagnosis of cystic fibrosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not wish to join the study or sign the consent form.
Select...
I have been diagnosed with severe acid reflux by a gastroenterologist.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in the mean GSAS score
Mean GSAS score in children with CF on GERD therapy

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Child with CF on GERD therapy without severe GERDExperimental Treatment1 Intervention
The GSAS will be completed at baseline, GERD therapy will be discontinued, and GSAS will be repeated 12 weeks later.

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,454 Previous Clinical Trials
2,971,591 Total Patients Enrolled
1 Trials studying Reflux
647 Patients Enrolled for Reflux
Cystic Fibrosis FoundationOTHER
197 Previous Clinical Trials
37,550 Total Patients Enrolled
Shatha YousefPrincipal InvestigatorDuke University Hospital
~13 spots leftby Apr 2025
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