Could a simple diet fix infant reflux better than drugs?

NCT ID NCT06255886

Recruiting now Disease control Sponsor: Odense University Hospital Source: ClinicalTrials.gov ↗

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.

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Conditions

The condition(s) this trial relates to.

gastroesophageal reflux disease Infant, Newborn, Diseases perinatal disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

GASTROESOPHAGEAL REFLUX INFANT, NEWBORN, DISEASES

Contacts and locations

Locations

Børnelægecentret v/Kasper Dalby
NOT_YET_RECRUITING

Odense, Region Syddanmark, 5000, Denmark
H.C Andersen Childrens' Hospital
NOT_YET_RECRUITING

Odense, Region Syddanmark, 5000, Denmark
Paediatric Department, Hospital of Southern Jutland
RECRUITING

Aabenraa, Region Syddanmark, 6200, Denmark

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