Measuring reflux symptoms in children with cystic fibrosis after stopping GERD treatment
Official title: Characteristics of Gastroesophageal Reflux in Children With Cystic Fibrosis
Run by Duke University · NCT06617013 · Data updated 2026-11-12
This study is trying to see how stopping GERD treatment affects reflux symptoms in children with cystic fibrosis aged 6-17.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 2 Years to 18 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Status | Recruiting |
| Started | October 23, 2024 |
| Main results expected | June 30, 2026 |
| Study ends | June 30, 2026 |
| Registry record updated | December 19, 2025 |
| Trial ID | NCT06617013 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with a history of severe GERD or those unwilling to stop GERD therapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Physical function and symptoms in children with cystic fibrosis
This project will compare breathing difficulty, exercise capacity, muscle strength, bladder control, and quality of life in children aged 6–18 with cystic fibrosis versus healthy peers to see where support is needed.
-
Investigating the impact of probiotics on gut health and quality of life in children with cystic fibrosis
This study is testing if giving probiotics can improve gut health and quality of life for children with cystic fibrosis.
-
Impact of CFTR Modulators on Sinus Health in Young Children with Cystic Fibrosis
This study is testing if a new treatment for cystic fibrosis can improve sinus health and smell in young children aged 2-8.
-
Using 19F MRI to study lung ventilation in children with cystic fibrosis
This study is testing a new MRI method to see how well children with mild cystic fibrosis breathe compared to healthy kids their age.
-
Detecting hidden small airway issues in cystic fibrosis patients
This study is trying to find hidden breathing problems in children and adults with cystic fibrosis who seem healthy on standard lung tests by looking at their lung scans and airflow patterns.
-
Inhaled CFTR mRNA for cystic fibrosis in Chinese patients aged 12 and older
This trial tests inhaled BMD003, a CFTR mRNA therapy, to see if it's safe and shows early signs of benefit in Chinese people 12 years and up with cystic fibrosis.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.