No registrations found.
ID
Source
Brief title
Health condition
risk reduction, cow's milk allergy
Sponsors and support
Dr Nicolaos Nicolaou, Asthma and Allergy Center LTD, 24 Nafpliou Street, St Raphael Court, 2nd floor, No. 21, 3025, Limassol, Cyprus
Dr. Nicoletta Iacovidou, Magginio Maternity Clinic, Aretaieio Hospital”, Athens, Greece
Intervention
Outcome measures
Primary outcome
Proven cow's milk protein allergy: atopic dermatitis and total allergic manifestations
Secondary outcome
Growth in weight, length and head circumference
Background 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.
Study objective
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.
Study design
Monthly visits during the first half year of life, and follow up at the age of 8 and 12 months using questionnaires.
Intervention
Partially hydrolyzed protein formula during the first 6 months of life. Control groups are standard infant formula and fully breast fed infants
Anne Schaafsma
Leeuwarden 8901 MA
The Netherlands
+31 (0)58 2992424
anne.schaafsma@frieslandcampina.com
Anne Schaafsma
Leeuwarden 8901 MA
The Netherlands
+31 (0)58 2992424
anne.schaafsma@frieslandcampina.com
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL6120 |
NTR-old | NTR6259 |
Other | : GND-02-2016 |