Prevention of Cow's Milk Allergy in Children

Milk Hypersensitivity Clinical Trial

Official title:

Use of Fermented Milk in Prevention of Cow's Milk Allergy in New Born and Infant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00792090
• Other study ID #: BL006
• Status: Completed
• Phase: N/A
• First received: November 14, 2008
• Last updated: November 14, 2008
• Start date: November 2003
• Est. completion date: July 2008

Study information

• Verified date: November 2008
• Source: Bledina
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Impact of fermented milk in prevention of cow's milk allergy in new born and infants

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: July 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypersensitivity
• Milk Hypersensitivity

Intervention

Other:
• Fermented milk
Formula used for non breastfed children or in complement of breastfeeding
• Standard milk
Formula used for non breastfed children or in complement of breastfeeding

Locations

Country	Name	City	State
France	Hôpital central	Nancy
France	Hôpital Saint Vincent de Paul	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Bledina	Optimed

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensibilisation and cow's milk allergy		4, 12 and 24 months	No
Secondary	Sensitization or allergy to other allergens		4, 12 and 24 months	No
Secondary	Atopic diseases (atopic dermatitis, asthma)		4, 12 and 24 months	No