Trials / Completed
CompletedNCT00159523
Impact in Off-spring of Mothers After Perinatal Daily Intake of a Probiotic
The Impact of Perinatal Daily Supplement of a Probiotic (Lactobacillus Rhamnosus GG), Given to Mothers, on Immunological Development, Atopic Sensitisation and Allergic Disease in Their Off-spring
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 416 (actual)
- Sponsor
- Norwegian University of Science and Technology · Academic / Other
- Sex
- All
- Age
- 30 Weeks – 36 Weeks
- Healthy volunteers
- Accepted
Summary
A probiotic (Lactobacillus rhamnosus GG) supplement to pregnant women the last four weeks of pregnancy and three months after birth is expected to give a 40% reduction in risk of atopic sensitisation and allergic disease at two years of age, compared to placebo.
Detailed description
To investigate how probiotics given to pregnant women during the last 4 weeks of pregnancy and the first 4 months after birth influence the establishment and composition of the gut microflora in children from birth until two years of age. At the same time to investigate the relationship between gut flora composition and the development of the immune system. To investigate the relationship between supplement of probiotics to pregnant and breast-feeding women, the microbial composition of the gut flora in their children, the development of the childrens' immune system, and the prevalence of atopic sensitisation and atopic disease at two years of age.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Probiotic | |
| BIOLOGICAL | placebo |
Timeline
- Start date
- 2003-12-01
- Primary completion
- 2007-09-01
- Completion
- 2007-09-01
- First posted
- 2005-09-12
- Last updated
- 2016-02-05
Locations
1 site across 1 country: Norway
Source: ClinicalTrials.gov record NCT00159523. Inclusion in this directory is not an endorsement.