Allergic Conditions Clinical Trial
Official title:
Primary Prevention of Allergic Disease in Early Child by Lactobacillus Reuteri
An altered microbial exposure may be partly responsible for the increase of allergic diseases
in populations with a western lifestyle. Activation of the immune system by microbes early in
life is probably required for an accurate maturation of the immune system. Probiotics, live
bacteria which are considered to confer health when ingested, have been suggested to prevent
eczema and sensitisation infants.
The aim of this study is to assess the effect of oral supplementation with the probiotic
bacterium Lactobacillus reuteri in infancy on the development of allergic disease and
sensitisation during the first 2 years of life and to examine mechanisms possibly underlying
eventual effects on allergic manifestations.
A follow up was performed at 7 years of age.
An altered microbial exposure may be partly responsible for the increase of allergic diseases
in populations with a western lifestyle. Activation of the immune system by microbes early in
life is probably required for an accurate maturation of the immune system. Probiotics, live
bacteria which are considered to confer health when ingested, have been suggested to prevent
eczema and sensitisation infants.
The aim of this study is to assess the effect of oral supplementation with the probiotic
bacterium Lactobacillus reuteri (L. reuteri) in infancy on the development of allergic
disease and sensitisation during the first 2 years of life and to examine mechanisms possibly
underlying eventual effects on allergic manifestations. In the study the development of
allergic disease will also be related prospectively to immunological, nutritional and
environmental factors.
The study is a prospective double-blind placebo-controlled multicenter trial, comprising 232
families with allergic disease. The families are recruited at the antenatal clinic, and the
mothers will receive L. reuteri ATCC 55730 (1 x 100 000 000 colony forming units, Biogaia AB,
Stockholm, Sweden) or placebo daily from gestational week 36 until delivery. Their babies
then will continue with the same study product from birth until 12 months of age and will be
followed up for another year. Clinical follow-up will be done at 1, 3, 6,12 and 24 months of
age and telephone interviews at 2,4,5, 8, 10 and 18 months. A questionnaire will be completed
on each occasion. Skin prick test will be performed at 6, 12 and 24 months of age. Venous
blood will be collected from the umbilical cord and at 6, 12 and 24 months and stored as
heparinized plasma or serum until assessment. Peripheral mononuclear blood cells (PBMC) will
be separated from the plasma samples before storage. Blood samples will also be collected
from the mother and father once during the study. The stool sample will be collected from the
mother during the 1 week after delivery and the infant at 5-7 days, 1 month, 3 months, 6
months, 12 months and 24 months of age. Saliva samples will be collected at 3, 6, 12 and 24
months of age and breast milk samples will be collected from the mother 1-3 days and 1 months
after delivery. The saliva, breast milk and plasma/serum samples will be stored in -20°C and
stool samples and the PBMC in -70°C until assessment.
A follow up was performed at 7 years of age focusing on allergic disease. Spirometry, skin
prick test was performed. Of the 188 completing the 2 year follow up, 184 also completed the
7 year follow up.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT02277483 -
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Phase 4 |