Clinical Trial: The Influence of Early and Continuous Exposure of Infants to Cow's Milk Formula on the Prevention of Milk Allergy

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: The Influence of Early and Continuous Exposure of Infants to Cow's Milk Formula on the Prevention of Milk Allergy

Brief Summary: Cow's milk protein (CMP) allergy is one of the most common food allergies and potentially a fatal one. Early feeding with CMP has been considered in the past as a risk factor for development of CMP allergy in high risk infants. Although other studies argue with this assumption and suggest early exposure to CMP might be protective against atopic dermatitis and CMP allergy. A cohort study that first introduction of CMP after 15-30 days of age, raised the risk for CMP allergy.The aim of this study is to investigate if early and continuous exposure to CMF will decrease CMP allergy rate.

Detailed Summary: Background: Cow's milk protein (CMP) allergy is one of the most common food allergies and potentially a fatal one. The incidence of milk allergy is 1.5-3% in the first year of life, but only 60% of the reactions are IgE mediated. CMP allergy tends to resolve in approximately 45-50% of the infants at 1 year of age, in 60-75% at the age of 2, and 85-90% at 3 years. The range for IgE mediated CMP allergy is 29-76%. A recent study suggested that the natural history of CMP allergy might have changed over time, with slower rates of resolution and a higher proportion of children with disease persisting into adolescence and adulthood. In the past it has been described that there is more incidence of CMP allergy in children from families with positive history of allergy. Early feeding with CMP has been considered in the past as a risk factor for development of CMP allergy in high risk infants. Although other studies argue with this assumption and suggest early exposure to CMP might be protective against atopic dermatitis and CMP allergy. A cohort study that first introduction of CMP after 15-30 days of age, raised the risk for CMP allergy. A recent study on peanut allergy found that continuous early exposure to peanut dramatically decreased the incidence of peanut allergy. The research in the field of food allergy and especially in CMP allergy is very alert those days. But as far as the investigators knowledge, there are no prospective studies from the first days of life that examined the influence of early and continuous exposure to cow's milk formula (CMF) on CMP allergy. The existing data related to CMP allergy is controversial and inconclusive. Thus, no one can rely on it to establish clear recommendations for parents when is the best time to combine CMF in the infants diet. Working hypothesis and aims: The aim of the study is to investigate if early and continuous exposure to CMF will decrease CMP allergy rate. The investigators assumption is that the rate of CMP allerg
Sponsor: Meir Medical Center

Current Primary Outcome: The incidence of cow's milk allergy in the intervention groups [ Time Frame: 1 year ]

Measure the rate of cow's milk allergy infants in each group and compare the rate of allergy between the groups.


Original Primary Outcome: The incidence of cow's milk allergy in the intervention groups [ Time Frame: 1 year ]

the rate of CMP allergy in the intervention groups and in infants who are only feed by CMF, will be lower than in the group of infants who are exclusively breast feed


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Meir Medical Center

Dates:
Date Received: May 25, 2016
Date Started: July 2016
Date Completion: December 2019
Last Updated: May 31, 2016
Last Verified: May 2016