Primary Prevention of Atopic Disease by Perinatal Administration of Probiotics
NCT00200954 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 157
Last updated 2008-08-18
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 disease during infancy.
Conditions
- Food Allergy
- Atopic Dermatitis
- Asthma
- Rhinitis
Interventions
- DIETARY_SUPPLEMENT
-
Probiotic bacteria
3 x 10e9 CFU of a mixture of probiotic bacteria, once daily to the pregnant mothers last 6 weeks of pregnancy.To their offspring during the first year of life.
- DIETARY_SUPPLEMENT
-
Placebo
The placebo consists of the carrier of the probiotic bacteria mixture, i.e. rice starch and maltodextran
Sponsors & Collaborators
-
UMC Utrecht
collaborator OTHER -
The Netherlands Asthma Foundation
lead OTHER
Principal Investigators
-
Maarten O Hoekstra, MD PhD · Wilhelmina Children's Hospital Utrecht (UMCU)
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-01-31
- Primary Completion
- 2007-12-31
- Completion
- 2008-08-31
Countries
- Netherlands
Study Locations
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