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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
416
Dep of Public health and general Practice
Trondheim, Norway
Atopic disease defined as atopic eczema, allergic rhino conjunctivitis or asthma at two years of age
Time frame: 2 years
Atopic sensitization
Time frame: 2 years
Positive skin prick test (SPT), elevated total IgE and elevated specific IgE
Time frame: 2 years
Intestinal microflora
Time frame: 2 years
Intestinal colonisation with LGG.
Time frame: 2 years
Oral cavity colonisation with LGG.
Time frame: 2 years
Immunomarkers
Time frame: 2 years
TGF in breastmilk
Time frame: 2 years
Cytokine profile from activated PBMC
Time frame: 2 years
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