A Randomized, controlled, cross-over Study to assess Hypoallergenicity of an extensively hydrolyzed whey protein Infant formula in children with cow's milk allergy using amino-based infant formula as a reference.

Phase 2

• Conditions: Cow's Milk Allergy; Cow's milk proteïne allergy; 10001708

• Registration Number: NL-OMON41369
• Lead Sponsor: utricia Research BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 18

Inclusion Criteria

- Children with a documented cow's milk allergy.
- Between birth and 3 years of age.
- Expected daily intake of at least 250ml of the study product during the open challenge.

Exclusion Criteria

- Children who receive breastfeeding more than twice daily during the week before inclusion.
- Confirmed history of anaphylactic reaction, including severe cardiovascular symptoms, severe laryngeal edema, and bronchus obstruction.
- Intolerance for lactose or any other component of the study product(s).
- Previous signs of allergy to any extensively hydrolyzed formula.
- Previous use of an amino acid formula due to (suspected) severe cow's milk allergy.
- Major congenital malformations.
-Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Incidence of immediate and/or delayed allergic reactions.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Anthropometrics, gastro-intestinal tolerability and faecal characteristics.<br /><br>Blood safety and tolerance parameters.</p><br>