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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages N/A - 2 Days
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Term and near term newborns (gestational age of at least 36 weeks) - normal birth weight.
  • - normal perinatal follow-up (physiological neonatal jaundice is not an exclusion criteria) - without congenital defects.

Exclusion Criteria:

  • - Preterm newborns.
  • - Congenital defects.
- Newborn suffering from acute event

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02785679
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Meir Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Ronit Confino- Cohen, MD
Principal Investigator Affiliation allergy and immunology unit, MeirMc
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOther
Overall Status Recruiting
Countries Israel
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Cow Milk Allergy, Newborns
Additional Details

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 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. Methods: Recruitment of 2,500 infants from first day of life and divide the participants into 4 groups: 1. Exclusive breast feeding. 2. Exclusive CMF feeding. 3. Breast feeding with 20 cc of CMF per day. 4. Breast feeding with one meal per day of CMF. The mother will complete a survey questionnaire before the labor. Infants will be followed for 1 year. During this follow-up period -the participants will be examined by an allergologist at the age of 2 month and 1 year. In between, the infants will be followed by a phone questionnaire once in a month. Specific CM IgE analysis from umbilical cord blood and skin test at 2 month of age will be performed. Inclusion criteria

  • - Term and near term newborns (gestational age of at least 36 weeks), normal birth weight, normal perinatal follow-up and without congenital defects.
Expected results: The rate of CMP allergy in the intervention groups and in the group on exclusively CMF feeding will be lower than in the group on exclusive breast feeding. Importance: If the investigators will be able to prove the study hypothesis (and even if not), it will have a significant influence on the diet recommendations for infants. Probable implications to Medicine: If the investigators will get the expected results, the recommendations that exist today for infant's feeding can be changed.

Arms & Interventions

Arms

No Intervention: Exclusive breast feeding

Exclusive breast feeding

No Intervention: Exclusive CMF feeding

Exclusive CMF feeding

Active Comparator: Breast feeding with small amount of CMF

Breast feeding with addition (as intervention) of 20 cc of cow's milk formula (CMF) per day

Active Comparator: Breast feeding with one meal of CMF

Breast feeding with addition (as intervention) of one meal per day of cow's milk formula (CMF)

Interventions

Dietary Supplement: - cow's milk formula

addition of cow's milk formula in two different dosage - one only 20ml per day and one group a full meal per day

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International Sites

Meir medical center, Kfar Saba, Israel

Status

Recruiting

Address

Meir medical center

Kfar Saba, ,

Site Contact

Idit Lachover - Roth, MD

idit.roth@clalit.org.il

972-54-3152585

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