NCT06481280View on ClinicalTrials.gov

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

NAActive, not recruitingINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

August 14, 2024

Primary Completion Date

January 31, 2026

Study Completion Date

June 30, 2026

Conditions
Cow's Milk Allergy
Interventions
DIETARY_SUPPLEMENT

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.

DIETARY_SUPPLEMENT

Placebo Formula

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

Trial Locations (2)

5000

Private practice Elena BRADATAN, Namur

00161

University Hospital - Umberto I Sapienza, Roma

All Listed Sponsors
collaborator

Slb Pharma

OTHER

lead

United Pharmaceuticals

INDUSTRY

NCT06481280 - Evaluation of Tolerance, Efficacy and Safety of an Hydrolyzed Formula in Infants With IgE/Non-IgE Mediated CMA. | Biotech Hunter | Biotech Hunter