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

NCT02785679 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2500

Last updated 2021-04-14

No results posted yet for this study

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.

Conditions

  • Cow Milk Allergy
  • Newborns

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

Sponsors & Collaborators

  • Schneider Children's Hospital

    collaborator OTHER

  • Meir Medical Center

    lead OTHER

Principal Investigators

  • Ronit Confino- Cohen, MD · allergy and immunology unit, MeirMc

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Hours
Max Age
2 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-20
Primary Completion
2021-08-31
Completion
2021-12-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02785679 on ClinicalTrials.gov