Primary Prevention of Atopic Disease by Perinatal Administration of Probiotics
1 other identifier
interventional
157
1 country
1
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 disease during infancy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2004
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedAugust 18, 2008
May 1, 2007
3.9 years
September 12, 2005
August 13, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence and severity of atopic disease at the age of 2 years. Incidence and prevalence of eczema
Follow-up at 3 months, 12 months, and 24 months
Secondary Outcomes (1)
Serum IgE, stool composition, cytokines produced by PBMNC's
Follow-up at 3 months, 12 months and 24 months
Study Arms (2)
placebo
PLACEBO COMPARATORplacebo group
2
ACTIVE COMPARATORProbiotic bacteria group
Interventions
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.
The placebo consists of the carrier of the probiotic bacteria mixture, i.e. rice starch and maltodextran
Eligibility Criteria
You may qualify if:
- Pregnant mothers were included if either they themselves or their husband plus one sibling suffered from present or past atopic disease
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Netherlands Asthma Foundationlead
- UMC Utrechtcollaborator
Study Sites (1)
Wilhelmina Children's Hospital (UMCU)
Utrecht, Utrecht, 3508AB, Netherlands
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maarten O Hoekstra, MD PhD
Wilhelmina Children's Hospital Utrecht (UMCU)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 20, 2005
Study Start
January 1, 2004
Primary Completion
December 1, 2007
Study Completion
August 1, 2008
Last Updated
August 18, 2008
Record last verified: 2007-05