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.

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. - SHINE

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41369

Enrollment

Registered

2012-10-16

Start date

2012-10-01

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cow's Milk Allergy Cow's milk proteïne allergy

Interventions

Test procuct: the upgrade of an extenstensively hydrolized formula based on extensively hydrolyzed whey proteins. Reference product: Neocate. Patients will take both products, each on one of the two

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Incidence of immediate and/or delayed allergic reactions.	—

Secondary

Measure	Time frame
Anthropometrics, gastro-intestinal tolerability and faecal characteristics. Blood safety and tolerance parameters.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)