Status:
COMPLETED
Primary Prevention of Atopic Disease by Perinatal Administration of Probiotics
Lead Sponsor:
The Netherlands Asthma Foundation
Collaborating Sponsors:
UMC Utrecht
Conditions:
Food Allergy
Atopic Dermatitis
Eligibility:
All Genders
20-45 years
Phase:
NA
Brief Summary
Administration of probiotics to pregnant women from an atopic family and subsequently to their high-risk newborns results in prevention of the incidence or in a decrease of the severity of atopic dise...
Detailed Description
Background. Atopic diseases are increasing in countries with a Western lifestyle. The hygiene hypothesis states that the increase in atopic disease could be due to reduced exposure to microbial antige...
Eligibility Criteria
Inclusion
- Pregnant mothers were included if either they themselves or their husband plus one sibling suffered from present or past atopic disease
Exclusion
- Maternal use of immunomodulatory drugs during pregnancy, the use of probiotics prior to the start of the study.
- Children were excluded from the study if their mother received antibiotic treatment during the last two weeks of pregnancy
- When the child was born preterm, i.e. before 37 weeks of gestation
- If the children received antibiotic treatment in the first two weeks of life
- If ingestion of the study product was difficult due to vomiting or feeding problems in general for longer than 3 weeks from birth
- If the children had other major medical problems
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
157 Patients enrolled
Trial Details
Trial ID
NCT00200954
Start Date
January 1 2004
End Date
August 1 2008
Last Update
August 18 2008
Active Locations (1)
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1
Wilhelmina Children's Hospital (UMCU)
Utrecht, Utrecht, Netherlands, 3508AB