Asthma Clinical Trial
Official title:
Prevention Allergic Disease of Infant With Probiotics During Pregnancy and Neonate
The purpose of this study is to determine whether childhood atopic disease decrease or not after allowing allergic mothers intake of probiotic (Lactobacillus GG) in second trimester, followed by infant intake for 6 months after birth.
The prevalence of atopy at Taiwan increased 8 times in past 20 years and also increased all
over the world. In our previous study, maternal atopic history rather than paternal one is
the major factor to effect infant eczema and IgE titers. This may be related to maternal
inheritance and environments during pregnancy. Kalliomaki et al. (Lancet, vol.357, p1076-9,
2001) presented that Lactobacillus GG used 2-4 weeks prenatally to mothers and 6 months
postnatally to infants was effective in prevention of early atopic disease in children at
high risk.
We designed a double-blind randomized placebo-controlled study to evaluate whether cord
blood IgE and childhood atopic disease decreased after allowing allergic mothers intake of
Lactobacillus GG in second trimester, followed by infant intake of Lactobacillus GG for 6
months after birth.
Materials and Methods:
1. Inclusion criteria: Pregnant women with atopic disease, which was determined with
atopic history, elevated total IgE > 100 kU/l and positive specific IgE.
2. Case number: 100 cases were collected in both control and study groups.
3. Study design: In a double blind randomized placebo-controlled study, eligible cases are
allowed to take Lactobacillus GG or placebo daily from gestational age of 24 weeks
until delivery in both groups.
In study group, Lactobacillus GG is given prenatally from gestational age of 24 weeks
to delivery for mothers and 6 months postnatally for infants.
In control group, placebo starch is given prenatally from gestational age of 24 weeks
for mothers to delivery and 6 months postnatally for infants.
4. Schedule of follow-up: Infant/child clinical symptoms and sign are evaluated and IgE
and specific IgE are tested in bloods from umbilical cords, infants in 1, 3 and 5 year
old.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
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