Phase 4 Gastro-oesophageal Reflux Disease Trial, Recruiting NCT05455359 Sponsor: Boston Children's Hospital Condition: Gastro-oesophageal Reflux Disease
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Phase 4 Gastro-oesophageal Reflux Disease Trial, Recruiting

NCT05455359
Recruiting Phase 4

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:

  • People between 5 and 21 years of age
  • People who receive more than 90% of their calories through a feeding tube and do not eat or drink by mouth
  • People who have been identified as being at high risk of aspiration pneumonia (where food or liquid enters the airway), based on a specific swallowing test using video imaging that showed problems protecting the airway
  • People who have a stable, non-worsening neurological condition (such as cerebral palsy) that causes physical or intellectual impairment and is not expected to get worse for at least one year
  • People who have ongoing breathing-related symptoms — such as coughing, choking, or needing suctioning to clear the airway — at least three times per week over the past four weeks

Who may not be able to join:

  • People whose neurological condition is progressive (meaning it is expected to worsen over time)
  • People who have previously had a specific stomach surgery called a Nissen fundoplication that remains intact
  • People who are currently taking any antibiotics, whether by mouth or inhaled, including those taken regularly to prevent infection
  • People who are currently taking, or have taken in the last four weeks, medications that reduce stomach acid (such as H2 blockers or proton pump inhibitors)
  • People who are fed through a tube that goes past the stomach into the small intestine (gastrojejunostomy), rather than through a standard stomach feeding tube (gastrostomy)

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 23 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Phone: 617-355-0897

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
Phase 4
Sponsor
Boston Children's Hospital
Registry
ClinicalTrials.gov
Start date
13 February 2025
Est. completion
31 May 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Pediatric Cough Quality of Life Questionnaire

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: 23 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