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van CCT (UK)

van CCT (UK)

Partial hydrolyzed protein in cows milk protein allergy risk reduction.

- candidate number10192
- NTR NumberNTR3003
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-jul-2011
- Secondary IDsNutr-MC-001-2011 FrieslandCampina
- Public TitlePartial hydrolyzed protein in cows milk protein allergy risk reduction.
- Scientific TitleCow milk protein allergy risk reduction of Friso Preventive HA in high risk full term born infants.
- hypothesisThere will be no significant difference in prevalence of allergy in infants with increased risk for CMA when fed with partially hydrolysed whey protein or extensively hydrolysed casein formula, at the age of 6 months.
- Healt Condition(s) or Problem(s) studiedCow's milk allergy, Infants with CMA risk
- Inclusion criteria1. Increased risk for allergy (mother, father, brother or sister with an allergic disease);
2. Full term newborn.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2011
- planned closingdate1-feb-2013
- Target number of participants200
- InterventionsFriso 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 with a high risk to develop cow milk allergy (CMA) because it contains medium-fragment proteins. 50% of the proteins have a molecular weight lower than 1500 dalton.

Friso Allergy care (Control):
Friso Allergy care infant formula is based on extensively hydrolysed casein protein. It is especially developed for infants with CMA diagnostic. 97% of the proteins have a molecular weight lower than 1500 dalton.

The duration of the intervention will be for 6 months.
- Primary outcome1. 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 outcomeThe moment of onset of cow’s milk protein allergy during the intervention period for both of the formulae.
- TimepointsT= 1 week;
T= 1 mo;
T= 2 mo;
T= 3 mo;
T= 6 mo.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES Miriam Contreras Fernandez
- CONTACT for SCIENTIFIC QUERIES Miriam Contreras Fernandez
- Sponsor/Initiator FrieslandCampina Innovation Infant &Toddler Nutrition
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summaryThe best protection, or the best preventive allergy strategy, starts with the prevention of early sensitization of the consumer to give the intestine and immune system time to mature. Maturation of the non-sensitized immune system creates normal oral tolerance instead of tolerance based on counterbalancing the hyper response.
The aim of the study is to confirm that partialy hydrolysed protein does not sensitize the immune system, similarly to the effects found in the extensively hydrolysed protein formula. The study will be performed in full term mexican infants.
- Main changes (audit trail)
- RECORD26-jul-2011 - 2-sep-2011

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