Prevention of Cow's Milk Allergy in Children
Primary Purpose
Milk Hypersensitivity
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Fermented milk
Standard milk
Sponsored by
About this trial
This is an interventional prevention trial for Milk Hypersensitivity focused on measuring allergy, cow's milk, sensibilisation, fermented milk, infant formula
Eligibility Criteria
Inclusion Criteria:
- mother before the 5th month of pregnancy
- mother agreeing to stop consumption of yogurts and fermented milks during the 3rd quarter of pregnancy
- mother agreeing to receive a calcium supplementation during the 3rd quarter of pregnancy
- atopic mother or father and at least another atopic member (sister or brother)
- parents having given written informed consent
- adhesion to eviction regimen for mother and child
- parents agreeing with a regular follow-up (3 visits and monthly phone call with the dietician)
Exclusion Criteria:
- mother in an exclusion period from another study
- parents refusing to sign the informed consent
- infant in a situation which could interfere with an optimal participation to the study, or which could represent a risk for the infant, according to the investigator
- known or suspected immunodeficiency in the family
Sites / Locations
- Hôpital central
- Hôpital Saint Vincent de Paul
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Fermented milk
Standard milk
Outcomes
Primary Outcome Measures
Sensibilisation and cow's milk allergy
Secondary Outcome Measures
Sensitization or allergy to other allergens
Atopic diseases (atopic dermatitis, asthma)
Full Information
NCT ID
NCT00792090
First Posted
November 14, 2008
Last Updated
November 14, 2008
Sponsor
Bledina
Collaborators
Optimed Medizinische Instrumente GmbH
1. Study Identification
Unique Protocol Identification Number
NCT00792090
Brief Title
Prevention of Cow's Milk Allergy in Children
Official Title
Use of Fermented Milk in Prevention of Cow's Milk Allergy in New Born and Infant
Study Type
Interventional
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bledina
Collaborators
Optimed Medizinische Instrumente GmbH
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Impact of fermented milk in prevention of cow's milk allergy in new born and infants
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Milk Hypersensitivity
Keywords
allergy, cow's milk, sensibilisation, fermented milk, infant formula
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
142 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Fermented milk
Arm Title
2
Arm Type
Active Comparator
Arm Description
Standard milk
Intervention Type
Other
Intervention Name(s)
Fermented milk
Intervention Description
Formula used for non breastfed children or in complement of breastfeeding
Intervention Type
Other
Intervention Name(s)
Standard milk
Intervention Description
Formula used for non breastfed children or in complement of breastfeeding
Primary Outcome Measure Information:
Title
Sensibilisation and cow's milk allergy
Time Frame
4, 12 and 24 months
Secondary Outcome Measure Information:
Title
Sensitization or allergy to other allergens
Time Frame
4, 12 and 24 months
Title
Atopic diseases (atopic dermatitis, asthma)
Time Frame
4, 12 and 24 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
mother before the 5th month of pregnancy
mother agreeing to stop consumption of yogurts and fermented milks during the 3rd quarter of pregnancy
mother agreeing to receive a calcium supplementation during the 3rd quarter of pregnancy
atopic mother or father and at least another atopic member (sister or brother)
parents having given written informed consent
adhesion to eviction regimen for mother and child
parents agreeing with a regular follow-up (3 visits and monthly phone call with the dietician)
Exclusion Criteria:
mother in an exclusion period from another study
parents refusing to sign the informed consent
infant in a situation which could interfere with an optimal participation to the study, or which could represent a risk for the infant, according to the investigator
known or suspected immunodeficiency in the family
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe Dupont, PhD
Organizational Affiliation
Hôpital Saint Vincent de Paul
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Denise-Anne Moneret-Vautrin, PhD
Organizational Affiliation
Hôpital central
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital central
City
Nancy
ZIP/Postal Code
57000
Country
France
Facility Name
Hôpital Saint Vincent de Paul
City
Paris
ZIP/Postal Code
75014
Country
France
12. IPD Sharing Statement
Learn more about this trial
Prevention of Cow's Milk Allergy in Children
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