Phase 4 Gastro-oesophageal Reflux Disease Trial, Recruiting
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:
- Babies who have been diagnosed with gastroesophageal reflux disease (GERD), which is a condition where stomach contents come back up into the food pipe
- Babies who were referred to the trial before their first birthday
- Babies who are older than 1 month at the time treatment begins
- Babies who have at least 3 reflux episodes per day on average
- Babies who are also experiencing at least one of the following: crying for no clear reason, discomfort or fussiness, trouble gaining weight or losing weight, refusing the breast or bottle, pauses in breathing, or arching of the back
Who may not be able to join:
- Babies who have been diagnosed with, or are suspected of having, a syndrome or genetic condition
- Babies who were born with significant physical abnormalities (minor ones may be acceptable — confirm with trial site)
- Babies who have had abdominal surgery
- Babies who have a metabolic disease
- Babies who have taken a proton pump inhibitor (a type of stomach acid medication) within the past week
- Babies who have a known allergy to proton pump inhibitors (a type of stomach acid medication)
- Babies who have a known allergy to cow's milk protein
- Babies who are currently on a diet that excludes cow's milk
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.
Contact this trial
Principal Investigator: Gitte Zachariassen, Professor, H.C Andersen Childrens Hospital, Odense University Hospital and Syddansk University (SDU)
Phone: +4521787136
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
Where this trial is recruiting
Primary endpoints
Change from baseline in reflux episodes in the fourth week of active treatment, compared to placebo
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.