NCT02785679

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 30, 2016

Completed
1.8 years until next milestone

Study Start

First participant enrolled

March 20, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

April 14, 2021

Status Verified

April 1, 2021

Enrollment Period

3.5 years

First QC Date

May 25, 2016

Last Update Submit

April 13, 2021

Conditions

Cow Milk AllergyNewborns

Keywords

AllergyCow's milkbreast feedingCow's milk formulaprevention

Outcome Measures

Primary Outcomes (1)

  • The incidence of cow's milk allergy in the intervention groups

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

    1 year

Study Arms (4)

Exclusive breast feeding

NO INTERVENTION

Exclusive breast feeding

Exclusive CMF feeding

NO INTERVENTION

Exclusive CMF feeding

Breast feeding with small amount of CMF

ACTIVE COMPARATOR

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

Dietary Supplement: cow's milk formula

Breast feeding with one meal of CMF

ACTIVE COMPARATOR

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

Dietary Supplement: cow's milk formula

Interventions

cow's milk formulaDIETARY_SUPPLEMENT

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

Breast feeding with one meal of CMFBreast feeding with small amount of CMF

Eligibility Criteria

Age2 Hours - 2 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Term and near term newborns (gestational age of at least 36 weeks)
  • normal birth weight

You may not qualify if:

  • without congenital defects
  • Preterm newborns
  • Congenital defects
  • Newborn suffering from acute event

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir medical center

Kfar Saba, Israel

RECRUITING

Related Publications (2)

  • Lachover-Roth I, Cohen-Engler A, Furman Y, Rosman Y, Meir-Shafrir K, Mozer-Mandel M, Farladansky-Gershnabel S, Biron-Shental T, Confino-Cohen R. Infants born during COVID-19 pandemic experience increased susceptibility to airway hyperresponsiveness. Front Allergy. 2024 Dec 16;5:1512182. doi: 10.3389/falgy.2024.1512182. eCollection 2024.

    PMID: 39737062DERIVED

  • Lachover-Roth I, Cohen-Engler A, Furman Y, Rosman Y, Meir-Shafrir K, Mozer-Mandel M, Farladansky-Gershnabel S, Biron-Shental T, Confino-Cohen R. Food allergy and infant feeding practices: Are they related? Ann Allergy Asthma Immunol. 2023 Sep;131(3):369-375.e3. doi: 10.1016/j.anai.2023.05.031. Epub 2023 Jun 1.

    PMID: 37270027DERIVED

MeSH Terms

Conditions

Milk HypersensitivityHypersensitivityBreast Feeding

Condition Hierarchy (Ancestors)

Food HypersensitivityHypersensitivity, ImmediateImmune System DiseasesFeeding BehaviorBehavior

Study Officials

  • Ronit Confino- Cohen, MD

    allergy and immunology unit, MeirMc

    STUDY DIRECTOR

Central Study Contacts

Idit Lachover- Roth, MD

CONTACT

972-9-7472320idit.roth@clalit.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2016

First Posted

May 30, 2016

Study Start

March 20, 2018

Primary Completion

August 31, 2021

Study Completion

December 31, 2021

Last Updated

April 14, 2021

Record last verified: 2021-04

Locations

IL(1)