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Partial hydrolyzed protein in cows milk protein allergy risk reduction.

Cow milk protein allergy risk reduction of Friso Preventive HA in high risk full term born infants.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24148
Enrollment
200
Registered
2011-07-26
Start date
2011-10-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Cow's milk allergy, infants with CMA risk

Interventions

Friso Preventive HA (Intervention): The primary characteristic of Friso Preventive HA is an infant formula based on partially hydrolysed whey protein. It is a product primary designed for infants wit

Sponsors

Laboratorios PiSa, Mexico IMSS Pachuca, Hidalgo, Mexico
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Increased risk for allergy (mother, father, brother or sister with an allergic disease); 2. Full term newborn.

Exclusion criteria

Exclusion criteria: 1. Severe acquired or congenital diseases; 2. Gestational age of less than 37 weeks; 3. Birth weight of less than 2500 grams; 4. Intake of any formulae with intact protein during the first week of life; 5. Breast feeding more than two weeks; 6. Symptoms of cow milk allergy at the time of inclusion: eczema, rashes; 7. Abnormalities in heart, liver, kidneys, or central nervous system; 8. Supplementary feeding during the first four months of life; 9. Use of medication over a longer period of time, which affects the outcome of the study; 10. Use of cream that contains casein or other milk proteins; 11. Incapability of the parents to comply with the study protocol.

Design outcomes

Primary

MeasureTime frame
1. Prevalence of cow's milk allergy, recorded on three-day diary allergy symptom, and confirmed by double blind challenge test; 2. Tolerance of the formula by three-day questionaire and crying diaries on each time point; 3. Antropometric measurements: Weight, length and head circumference, on each time point.

Secondary

MeasureTime frame
The moment of onset of cow’s milk protein allergy during the intervention period for both of the formulae.

Contacts

Public ContactMiriam Contreras Fernandez

P.O. box 226

miriam.contreras@frieslandcampina.com+31 (0)58 2992814

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)