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NCT06617013 · ClinicalTrials.gov registry record · NA
GERD in Children With Cystic Fibrosis
A NA study of Cystic Fibrosis in Children and GERD in Children, sponsored by Duke University.
- Recruiting
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT06617013: Recruiting NA study of Cystic Fibrosis in Children and GERD in Children, sponsored by Duke University.
NCT06617013 is a NA study of Cystic Fibrosis in Children and GERD in Children that is actively recruiting participants, run by Duke University. The registered enrollment target is 20 participants, below the 87-participant average among 6 other Cystic Fibrosis in Children trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06617013, a NA study of Cystic Fibrosis in Children and GERD in Children, is actively recruiting participants, sponsored by Duke University.
- RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Discontinuation of GERD therapy
Study Locations (1)
North Carolina
- Duke University Hospital - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-10-23 |
| Est. Completion | 2026-06-30 |
| Phase | NA |
What NCT06617013 shows while recruiting
NCT06617013 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 87-participant average among 6 other Cystic Fibrosis in Children trials with a reported enrollment target (77% lower).
The record links to 2 conditions, with Cystic Fibrosis in Children appearing as the primary indexed condition, and to 1 intervention - of which Discontinuation of GERD therapy is the first listed.
NCT06617013 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT06617013 about?
NCT06617013 is a clinical study titled "GERD in Children With Cystic Fibrosis". 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.
What is the current status of trial NCT06617013?
This trial is currently recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2024-10-23. Estimated completion is 2026-06-30.
What conditions does trial NCT06617013 study?
This clinical trial studies the following conditions: Cystic Fibrosis in Children, GERD in Children.
What interventions are being tested in trial NCT06617013?
The interventions under investigation include: Discontinuation of GERD therapy (OTHER).
Who is sponsoring clinical trial NCT06617013?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06617013 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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