GERD in ChildrenNCT06617013
GERD in Children With Cystic Fibrosis
A study testing Discontinuation of GERD therapy in people with GERD in Children and Cystic Fibrosis in Children, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- GERD in Children, Cystic Fibrosis in Children
- What is being tested?
- Discontinuation of GERD therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Declining to participate in the study or sign consent
- History of severe GERD per gastroenterology diagnosis and documentation
- GSAS score >80
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Shatha Yousef, MD contact
United States1 site, 1 recruiting
- Recruiting
Duke University Hospital
Durham, North Carolina, 27710
Yara Salameh, MF, 919-684-8111, yara.salameh@duke.edu
About this study
Official title: Characteristics of Gastroesophageal Reflux 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.
- Conditions
- GERD in Children, Cystic Fibrosis in Children
- Being tested
- Discontinuation of GERD therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discontinuation of GERD therapyOther
GERD therapy will be discontinued at time of enrollment.
| Study group | Role | What they receive |
|---|---|---|
| Child with cystic fibrosis (CF) on GERD therapy without severe GERD | Experimental | The GSAS will be completed at baseline, GERD therapy will be discontinued, and GSAS will be repeated 12 weeks later. Receives: Other: Discontinuation of GERD therapy |
| Child with cystic fibrosis (CF) | No intervention | The GSAS will be completed at baseline. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the mean GSAS score (only if GERD medication discontinued)
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.
Measured: baseline and 12 weeks
Mean GSAS score in children with CF on GERD therapy
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.
Measured: Baseline
Mean GSAS score in children with CF not on GERD therapy
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start23 Oct 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERD in ChildrenStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Responsible party
- Sponsor
- Investigators
- Shatha Yousef, Principal investigator, Duke University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06617013
- Sponsor's protocol ID
- PRO00115374
- Status last verified
- Dec 2025
- First submitted
- 25 Sep 2024
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Gastroesophageal Reflux in Children With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT06617013
- Acronym / sponsor ID
- PRO00115374
- Conditions
- GERD in Children, Cystic Fibrosis in Children
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Study start
- 23 Oct 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 27 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Child with cystic fibrosis (CF) on GERD therapy without severe GERD | Experimental | Other: Discontinuation of GERD therapyThe GSAS will be completed at baseline, GERD therapy will be discontinued, and GSAS will be repeated 12 weeks later. |
| Child with cystic fibrosis (CF) | No intervention | –The GSAS will be completed at baseline. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Declining to participate in the study or sign consent
- History of severe GERD per gastroenterology diagnosis and documentation
- GSAS score >80
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Discontinuation of GERD therapyGERD therapy will be discontinued at time of enrollment. | Other | Child with cystic fibrosis (CF) on GERD therapy without severe GERD |
Primary outcome
Change from baseline in the mean GSAS score (only if GERD medication discontinued)
Time frame: 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 therapy
Time frame: Baseline
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 therapy
Time frame: Baseline
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shatha Yousef, MD contact
Shatha Yousef principal investigator
Duke University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Discontinuation of GERD therapy in people with GERD in Children and Cystic Fibrosis in Children, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yara Salameh, MF (919-684-8111, yara.salameh@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the mean GSAS score (only if GERD medication discontinued) (time frame: baseline and 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.