Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New formula aims to soothe baby milk allergies

NCT ID NCT07342621

Symptom relief Sponsor: Outcomes'10 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a special infant formula designed for babies with cow's milk protein allergy. The formula includes added prebiotics, probiotics, and a human milk oligosaccharide to help ease allergy symptoms. About 41 infants under 10 months old will use the formula for 4 weeks, and doctors will track changes in symptoms like skin rashes or stomach issues.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
extensively hydrolysed whey-based formula with synbiotics (scGOS/lcFOS 9:1 and Bifidobacterium breve M-16V) and human milk oligosaccharide 2'-fucosyllactose (2'-FL)
What this could lead to
If it works, this could provide a better-tolerated formula that reduces allergy symptoms in infants with cow's milk protein allergy.
What could go wrong
This is a small, early-phase study with only 41 infants and no placebo group, so results may not be conclusive or widely applicable.

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.

Participants

About 41 people

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

Started

Feb 2025

Expected to finish

Apr 2026

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

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

Who is studied

Infants under 10 months of age with suspected or recently confirmed cow's milk protein allergy (CMPA) who are initiating the use of a hypoallergenic formula as part of routine clinical management. All participants will receive an extensively hydrolyzed whey-based formula containing synbiotics and 2'-fucosyllactose (2'-FL) and will be followed prospectively for four weeks.

Ages

Up to 10 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: * Infants under 10 months of age at study start (Visit 1). * Suspected or recently confirmed cow's milk protein allergy (CMPA), as determined by the investigator. * Already formula-fed, or parents/legal guardians have decided to initiate formula feeding. * Inclusion in the study coincides with the first prescription of a hypoallergenic formula. * Written informed consent obtained from parents or legal guardians in accordance with local regulations. Exclusion Criteria: * Infants with functional gastrointestinal symptoms in whom atopy or food allergy is not suspected. * Infants who have previously used an extensively hydrolyzed formula (EHF), an amino acid-based formula (AAF), a rice hydrolysate formula, or a soy-based formula. * Infants who have previously used a partially hydrolyzed formula for the prevention of cow's milk protein allergy (CMPA). * Infants for whom an amino acid-based formula (AAF) is more appropriate as first-line management, including severe forms of CMPA. * Contraindications to the use of synbiotics (e.g., preterm infants \<40 weeks of corrected gestational age at study start, immunodeficiency, short bowel syndrome, parenteral nutrition, post-pyloric feeding, central venous catheter, oncology treatment, or graft-versus-host disease). * Any other condition, as assessed by the investigator, that contraindicates the use of an extensively hydrolyzed formula. * Any other circumstance, as assessed by the investigator, indicating that the parents or legal guardians are not capable of complying with the study procedures.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Cow's milk protein allergy (CMPA) are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

food allergy Heiner syndrome Infant Nutrition Disorders Milk Hypersensitivity nutritional disorder

As listed by the trial registrant

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

Cow's milk protein allergy (CMPA) Food hypersensitivity Gut microbiota Infant nutrition disorders

How to take part

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

  1. The places running it

    13 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

  • Alboraya Health centre

    RECRUITING

    Valencia, Valencia, 46120, Spain

  • Cañada Health centre

    RECRUITING

    Valencia, Valencia, 46182, Spain

  • Eliana Health centre

    RECRUITING

    Valencia, Valencia, 46183, Spain

  • Malva-rosa Health centre

    RECRUITING

    Valencia, Valencia, 46011, Spain

  • Miguel Servet Health centre

    RECRUITING

    Valencia, Valencia, 46025, Spain

  • Quironsalud Valencia Hospital

    RECRUITING

    Valencia, Valencia, 46004, Spain

  • República Argentina Health centre

    RECRUITING

    Valencia, Valencia, 46021, Spain

  • Salvador Pau Health centre

    RECRUITING

    Valencia, Valencia, 46021, Spain

  • Serrería 2 Health Centre

    RECRUITING

    Valencia, Valencia, 46022, Spain

  • Serrería I Health Centre

    RECRUITING

    Valencia, Valencia, 46022, Spain

  • Trafalgar Health centre

    RECRUITING

    Valencia, Valencia, 46023, Spain

  • Trinitat Health centre

    RECRUITING

    Valencia, Valencia, 46010, Spain

  • Trinitat Health centre

    RECRUITING

    Valencia, Valencia, 46160, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.