Gastro-oesophageal Reflux Disease Trial, Recruiting NCT06617013 Sponsor: Duke University Condition: Gastro-oesophageal Reflux Disease
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Gastro-oesophageal Reflux Disease Trial, Recruiting

NCT06617013
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Children between 2 and 18 years old who have been diagnosed with Cystic Fibrosis (CF), confirmed either by a sweat test or by having 2 known CF-causing gene changes
  • A parent or guardian (and the child if old enough) must be willing to sign a consent form agreeing to take part

Who may not be able to join:

  • Anyone who does not want to take part in the study or is unwilling to sign the consent form
  • Children who have been diagnosed by a stomach/digestive specialist with a severe form of acid reflux (a condition where stomach acid frequently flows back up into the food pipe)
  • Children who score higher than 80 on something called the GSAS score, which is a tool used to measure digestive symptoms (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Shatha Yousef, Duke University Hospital

Phone: 919-684-8111

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Registry
ClinicalTrials.gov
Start date
23 October 2024
Est. completion
30 June 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change from baseline in the mean GSAS score (only if GERD medication discontinued); Mean GSAS score in children with CF on GERD therapy; Mean GSAS score in children with CF not on GERD therapy

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov