Prevention of Cow's Milk Allergy in Children

Bledina

Status: Completed

Conditions: Milk Hypersensitivity

Treatments: Other: Fermented milk; Other: Standard milk

Study type: Interventional

Funder types: Industry

Identifiers

NCT00792090

BL006

Details and patient eligibility

About

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

Enrollment: 142 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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142 participants in 2 patient groups

1

Experimental group

Description:

Fermented milk

Treatment:

Other: Fermented milk

2

Active Comparator group

Description:

Standard milk

Treatment:

Other: Standard milk