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Could a simple diet fix infant reflux better than drugs?

NCT ID NCT06255886

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 96 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 month to 1 year

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Infants diagnosed with gastroesophageal reflux disease (GERD) * Age \< 1 year at the time of referral * Age \>1 month at start of treatment * At least 3 reflux episodes/daily in average * At least one of following troublesome symptoms are present: Crying of unknown reason, discomfort/irritability, problems gaining weight/ weightloss, rejects the breast or bottle, apnea, back-arching. Exclusion Criteria: * Children with diagnosed or suspected syndrome /genetic disorder * Congenital malformations (minor deformities are excepted) * Abdominal surgery * Metabolic disease * Treatment with proton pump inhibitor within the last week * Allergy for proton pump inhibitors * Allergy for cow milk protein * Infants on Cow's milk free diet

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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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