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Clinical Trials in Italy / NCT06481280
Active, not recruiting Not applicable

Evaluation of Tolerance, Efficacy and Safety of an Hydrolyzed Formula in Infants With IgE/Non-IgE Mediated CMA.

NCT06481280 · tracked via the Priya Life Science Italy tracker
Sponsor
United Pharmaceuticals
Phase
Not applicable
Started
2024-08-14
Last updated
2025-01-07

Condition(s) studied

Cow's Milk Allergy

Investigational drug(s) / intervention(s)

Test FormulaPlacebo Formula

Test Formula: Infants will receive an extensively hydrolyzed formula during the double-blind placebo-controlled food challenge (DBPCFC) and will continue on this formula during the open-label feeding phase if they tolerate it.

Placebo Formula: Infants will receive a placebo formula during the DBPCFC to compare against the test formula.

Study summary

The aim of this interventional study is to assess the hypoallergenicity of a new formula in infants having a cow milk allergy (CMA), whatever the type of CMA, meaning in both IgE-mediated and non-IgE-mediated CMA patients.

This will be tested through a double-blind placebo controlled food challenge (DBPCFC) taking place over 2 or 3 separate days, in hospital.

If the child tolerates the tested formula during the DBPCFC, he will be fed with the test formula during the second study phase. There will be monthly visit and parents will be asked to fill in diaries.

Eligibility

Sex
ALL
Min age
1 Month
Max age
24 Months
Healthy volunteers
No
Inclusion Criteria: * between 1 and 24 months old * having a CMA proven in the last 3 months prior to inclusion * free of clinical allergic symptoms for at least one week (i.e., successfully fed an elimination diet) * whose parent(s)/legal guardian(s) signed the informed consent form. Main Exclusion Criteria: * Children mainly (\>1 breastfeeding/day) or exclusively breastfed, with maternal willingness to continue breast-feeding * Children with a mean formula intake lower than 250 ml/day * Children with past anaphylactic reaction(s) * Children with chronic (non acute) FPIES \-- Children presenting with any situation which, according to the investigator, may interfere with the study participation, or lead to a particular risk for the subject, * Children already participating in another clinical trial

Primary outcome measure(s)

  • Hypoallergenicity of the formula — 7 days
    the percentage of children tolerating the formula during the double blind placebo controlled food challenge

Trial sites (2)

FacilityCityRegionStatus
Private practice Elena BRADATAN Namur Begium
University Hospital - Umberto I Sapienza Roma Italy

More United Pharmaceuticals trials in Italy

Study on the Efficacy and Tolerance of a New Anti-regurgitation Infant Formula (STELLAR) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06481280 on ClinicalTrials.gov ↗ ← All trials in Italy