New formula aims to help Milk-Allergic babies keep food down

NCT ID NCT07592182

Not yet recruiting Disease control Sponsor: Lactalis Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests whether a special anti-regurgitation formula, made from extensively hydrolysed casein, is safe and well-tolerated in infants with cow's milk protein allergy (CMPA). About 55 babies aged 1 to 9 months will take part. The formula is given in a controlled food challenge, and then over a longer period to check growth and allergy symptoms. The goal is to provide a better feeding option for infants who both have CMPA and spit up frequently.

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 anti-regurgitation casein-based formula
What this could lead to
If successful, this formula could offer a safe, ready-to-use option for infants with cow's milk protein allergy who also have reflux, reducing the need for more expensive or restrictive alternatives.
What could go wrong
This is a small, early-stage study (55 infants) that has not yet started recruiting. The formula may still trigger allergic reactions in some babies, and results may not apply to all infants with CMPA.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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