|- candidate number||26932|
|- NTR Number||NTR6259|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||20-mrt-2017|
|- Secondary IDs||GND-02-2016 |
|- Public Title||Reduction of cow’s milk protein allergy risk by using a formula with partially hydrolyzed whey protein.|
|- Scientific Title||The cow’s milk protein allergy risk reducing effect of a partially hydrolyzed infant formula: Multicenter, Placebo-Controlled trial|
|- hypothesis||The preventive HA formula will show on average a 40% risk-reduction for AD (54% when AD is not present in family history and 22% when AD is present in the family history) as compared to a standard formula.|
2) The preventive HA will show a 30% risk reduction for total allergic manifestations, as compared to standard formula.
|- Healt Condition(s) or Problem(s) studied||Cow's milk allergy|
|- Inclusion criteria||• Gestational age ≥37 weeks|
• Younger than 5 days (with regard to time to decide on participation)
• At least one of the parents or siblings has or had a documented allergy.
• Apparently healthy, no symptoms of allergy.
• Being breast fed or provided with extremely hydrolyzed formula from birth onwards
• Being available for follow up until the age of 6 months
• Willing to fill in two questionnaires at infant’s age of 8 and 12 months
• Written informed consent
|- Exclusion criteria||• Severe acquired or congenital diseases, mental or physical disorders, symptoms of allergy according to the SCORAD or ComiSS forms|
• Gestational age <37 weeks
• Birth weight <2500 g
• Age >4 days
• No parents or siblings with documented allergy
• Infants who have been fed standard or partially/extensively hydrolyzed infant formula other than extremely hydrolyzed formula during the days of life.
• Incapability of parents to comply with the study protocol.
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-apr-2017|
|- planned closingdate||31-dec-2018|
|- Target number of participants||750|
|- Interventions||Partially hydrolyzed protein formula during the first 6 months of life. Control groups are standard infant formula and fully breast fed infants|
|- Primary outcome||Proven cow's milk protein allergy: atopic dermatitis and total allergic manifestations|
|- Secondary outcome||Growth in weight, length and head circumference|
|- Timepoints||Monthly visits during the first half year of life, and follow up at the age of 8 and 12 months using questionnaires.|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| Anne Schaafsma|
|- CONTACT for SCIENTIFIC QUERIES|| Anne Schaafsma|
|- Sponsor/Initiator ||Medical University of Varna, Asthma and Allergy Center LTD, Magginio Maternity Clinic, Aretaieio Hospital|
(Source(s) of Monetary or Material Support)
|- Brief summary||In the present multi-centre study the Cow’s Milk Allergy (CMA) risk reduction of apreventive HA (Hypo Allergenic) formula is studied in a high risk (based on family history of allergies) group of infants, as compared to standard infant formula and fully breast milk fed infants, during the first 6 months of life. During this period the infants will visit the researchers every month to evaluate growth and symptoms of allergy. In a follow up study at the ages of 8 and 12 months the incidence of allergic symptoms will be monitored by questionnaires, whereas growth will be measured at the age of 12 months. This part of the study (2nd half year of life) however will be analyzed separately and is not part of the present main study. |
The design of the present study is in particular based on the German Infant Nutritional Intervention Study (GINI). The read-outs of this study will be: 1) allergic/atopic manifestations (all manifestations and atopic dermatitis in particular) to show the product’s efficacy, and 2) growth (weight, length, head circumference) for safety and suitability of the product. In case of allergic/atopic manifestations, a proper diagnosis will take place.
|- Main changes (audit trail)|
|- RECORD||20-mrt-2017 - 29-apr-2017|