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New formula aims to soothe baby milk allergies

NCT ID NCT07342621

Recruiting now Symptom relief Sponsor: Outcomes'10 Source: ClinicalTrials.gov ↗

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.

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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

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

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