Prevention of Cow's Milk Allergy in Children

Not Applicable

Completed

• Conditions: Milk Hypersensitivity
• Interventions: Other: Fermented milk; Other: Standard milk

• Registration Number: NCT00792090
• Lead Sponsor: Bledina

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-11
• Primary Completion: 2008-05
• Study Completion: 2008-07
• Status Verified: 2008-11
• Study First Submitted: 2008-11-14
• Study First Submitted QC: 2008-11-14
• Last Update Submitted: 2008-11-14
• Study First Posted: 2008-11-17
• Last Update Posted: 2008-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

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)

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Fermented milk	Fermented milk
2	Standard milk	Standard milk

Primary Outcome Measures

Name	Time	Method
Sensibilisation and cow's milk allergy	4, 12 and 24 months

Secondary Outcome Measures

Name	Time	Method
Sensitization or allergy to other allergens	4, 12 and 24 months
Atopic diseases (atopic dermatitis, asthma)	4, 12 and 24 months

Trial Locations

Locations (2)

Hôpital central; 🇫🇷 Nancy, France

Hôpital Saint Vincent de Paul; 🇫🇷 Paris, France