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New baby formula aims to cut down Spit-Up

NCT ID NCT04358146

Symptom relief Sponsor: United Pharmaceuticals 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a new infant formula designed to reduce how often babies spit up. About 346 healthy, full-term infants who spit up at least 4 times a day will receive either the new formula or a standard one. Researchers will track changes in spit-up frequency and severity over 90 days to see if the new formula helps.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 346 people

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

Started

Mar 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

2 weeks to 4 months

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: * ≥ 2 regurgitation episodes per day during the last 2 weeks and ≥ 4 regurgitation episodes per day in average during the last 2 days, * exclusive or predominant formula feeding * whose parents signed informed consent Exclusion Criteria: * preterm infants or birthweight \<2500g * Post enteritis lactose intolerance * Suspected or diagnosed cow's milk protein allergy requiring an eviction diet * Use of medications that may interfere with regurgitation or gastrointestinal transit (such as alginates, laxatives, antibiotics...). All these medications have to be stopped at least 7 days before inclusion visit (V1) * Infants presenting with any situation which, according to the investigator, may interfere with the study participation, or lead to a particular risk for the subject

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Conditions

The condition(s) this trial relates to.

gastroesophageal reflux disease

As listed by the trial registrant

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

Gastroesophageal reflux in children

How to take part

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

  1. The places running it

    10 sites in 4 countries. 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

  • Center_01

    RECRUITING

    Athens, Greece

  • Center_02

    RECRUITING

    Étampes, France

  • Center_05

    RECRUITING

    Libourne, France

  • Center_08

    RECRUITING

    Vincennes, France

  • Center_09

    ACTIVE_NOT_RECRUITING

    Castelnau-le-Lez, France

  • Center_11

    RECRUITING

    Thessaloniki, Greece

  • Center_12

    RECRUITING

    Naples, Italy

  • Center_13

    RECRUITING

    Naples, Italy

  • Center_14

    ACTIVE_NOT_RECRUITING

    Namur, Belgium

  • Center_15

    RECRUITING

    Thuin, Belgium

  • Center_16

    RECRUITING

    Nice, France

  • Centre_10

    RECRUITING

    Maromme, France