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Reduction of cow’s milk protein allergy risk by using a formula with partially hydrolyzed whey protein.

The cow’s milk protein allergy risk reducing effect of a partially hydrolyzed infant formula: Multicenter, Placebo-Controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25443
Enrollment
750
Registered
2017-03-20
Start date
2017-04-01
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

risk reduction, cow's milk allergy

Interventions

Partially hydrolyzed protein formula during the first 6 months of life. Control groups are standard infant formula and fully breast fed infants

Sponsors

Dr. Rouzha Pancheva, Prof. Dr. Paraskev Stoyanov" Medical University of Varna, 55 "Marin Drinov" Str., 9002 Varna, Bulgaria 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
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: • Severe acquired or congenital diseases, mental or physical disorders, symptoms of allergy according to the SCORAD or ComiSS forms • Gestational 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 outcomes

Primary

MeasureTime frame
Proven cow's milk protein allergy: atopic dermatitis and total allergic manifestations

Secondary

MeasureTime frame
Growth in weight, length and head circumference

Contacts

Public ContactAnne Schaafsma

P.O.Box 226

anne.schaafsma@frieslandcampina.com+31 (0)58 2992424

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)