Could a simple diet fix infant reflux better than drugs?
NCT ID NCT06255886
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether removing cow's milk protein from the diet (via mother's diet or special formula) works better than the drug omeprazole for treating gastroesophageal reflux disease (GERD) in infants under 1 year old. About 96 babies with GERD will be randomly assigned to one of three groups: diet change, omeprazole, or placebo. Parents will track reflux episodes daily using an app. The goal is to find the safest and most effective first-line treatment for infant reflux.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
Active substance
Omeprazole (a proton pump inhibitor) and a cow-milk-protein-free diet
What this could lead to
If this trial succeeds, it could provide strong evidence that a simple diet change is more effective and safer than medication for infant reflux, potentially changing standard care.
What could go wrong
This is a Phase 4 trial with only 96 infants, so results may not apply to all cases. The study relies on parent-reported symptoms, which can be subjective, and the diet change may be difficult for some families to follow.
Disclaimer
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Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Study contacts
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Contact
Phone: •••-•••-•••• Email: •••••@•••••
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Contact
Phone: •••-•••-•••• Email: •••••@•••••
Locations
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Børnelægecentret v/Kasper Dalby
NOT_YET_RECRUITINGOdense, Region Syddanmark, 5000, Denmark
Contact Phone: •••-•••-•••• Email: •••••@•••••
Contact
Contact Email: •••••@•••••
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H.C Andersen Childrens' Hospital
NOT_YET_RECRUITINGOdense, Region Syddanmark, 5000, Denmark
Contact Phone: •••-•••-•••• Email: •••••@•••••
Contact
Contact Email: •••••@•••••
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Paediatric Department, Hospital of Southern Jutland
RECRUITINGAabenraa, Region Syddanmark, 6200, Denmark
Contact Email: •••••@•••••
Contact Phone: •••-•••-•••• Email: •••••@•••••
Contact