- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02785679
The Influence of Early and Continuous Exposure of Infants to Cow's Milk Formula on the Prevention of Milk Allergy
April 13, 2021 updated by: Meir Medical Center
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Anticipated)
2500
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Idit Lachover- Roth, MD
- Phone Number: 972-9-7472320
- Email: idit.roth@clalit.org.il
Study Locations
-
-
-
Kfar Saba, Israel
- Recruiting
- Meir Medical Center
-
Contact:
- Idit Lachover - Roth, MD
- Phone Number: 972-54-3152585
- Email: idit.roth@clalit.org.il
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 hours to 2 days (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Exclusive breast feeding
|
|
No Intervention: 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
|
addition of cow's milk formula in two different dosage - one only 20ml per day and one group a full meal 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)
|
addition of cow's milk formula in two different dosage - one only 20ml per day and one group a full meal per day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Ronit Confino- Cohen, MD, allergy and immunology unit, MeirMc
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 20, 2018
Primary Completion (Anticipated)
August 31, 2021
Study Completion (Anticipated)
December 31, 2021
Study Registration Dates
First Submitted
May 25, 2016
First Submitted That Met QC Criteria
May 27, 2016
First Posted (Estimate)
May 30, 2016
Study Record Updates
Last Update Posted (Actual)
April 14, 2021
Last Update Submitted That Met QC Criteria
April 13, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 011-16-MMC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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