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Completed

NCT Number: NCT00792090

Prevention of Cow's Milk Allergy in Children

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

Completed

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Key information

Conditions

Milk Hypersensitivity Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital central, Nancy, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fermented milk

Other

Formula used for non breastfed children or in complement of breastfeeding

Standard milk

Other

Formula used for non breastfed children or in complement of breastfeeding

Primary outcomes

  1. Sensibilisation and cow's milk allergy

    Time frame: 4, 12 and 24 months

Secondary outcomes

  1. Sensitization or allergy to other allergens

    Time frame: 4, 12 and 24 months

  2. Atopic diseases (atopic dermatitis, asthma)

    Time frame: 4, 12 and 24 months

Sponsors and collaborators

Lead sponsor

Bledina

Industry

Collaborators

  • Optimed Medizinische Instrumente GmbH

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Nov 17, 2008
Registry last updated
Nov 17, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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