Measuring reflux symptoms in children with cystic fibrosis after stopping GERD treatment
Characteristics of Gastroesophageal Reflux in Children With Cystic Fibrosis
This study is trying to see how stopping GERD treatment affects reflux symptoms in children with cystic fibrosis aged 6-17.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 2 Years to 18 Years |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT06617013 on ClinicalTrials.gov |
What this trial studies
This study aims to assess reflux symptoms in children aged 6-17 with cystic fibrosis who are currently receiving treatment for gastroesophageal reflux disease (GERD). Participants will complete a survey to evaluate their symptoms after discontinuing GERD therapy. The study will monitor changes in symptoms to better understand the impact of stopping treatment on this patient population. The goal is to gather data that could inform future treatment approaches for managing GERD in children with cystic fibrosis.
Who should consider this trial
Good fit: Ideal candidates are children aged 6-17 with a confirmed diagnosis of cystic fibrosis and stable GERD medication for at least three months.
Not a fit: Patients with a history of severe GERD or those unwilling to stop GERD therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for GERD in children with cystic fibrosis.
How similar studies have performed: While there may be studies on GERD in children, this specific approach of monitoring symptom changes after treatment discontinuation in cystic fibrosis patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Durham, North Carolina
- Duke University Hospital — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Shatha Yousef — Duke University Hospital
- Study coordinator: Yara Salameh, MF
- Email: yara.salameh@duke.edu
- Phone: 919-684-8111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.