Prevention Allergic Disease of Infant With Probiotics During Pregnancy and Neonatal Period
|Atopic Dermatitis Allergic Rhinitis Asthma||Dietary Supplement: Lactobacillus rhamnosus GG||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
|Official Title:||Prevention Allergic Disease of Infant With Probiotics During Pregnancy and Neonate|
- Prevalence of atopic disease in infant [ Time Frame: two years ]
|Study Start Date:||April 2005|
|Study Completion Date:||April 2010|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
Experimental: probiotics & allergy
Dietary Supplement: Lactobacillus rhamnosus GG
use Lactobacillus rhamnosus GG in pregnant women from gestational 26 weeks till newborn 6 months
Other Name: Brand names: Culturelle DS, Culturelle HS
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:
- Inclusion criteria: Pregnant women with atopic disease, which was determined with atopic history, elevated total IgE > 100 kU/l and positive specific IgE.
- Case number: 100 cases were collected in both control and study groups.
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00325273
|Kaohsiung Chang Gung Memorial Hospital|
|Kaohsiung, Niao-Sung, Taiwan, 833|
|Principal Investigator:||Chia-yu Ou, MD||Chang Gung Memorial Hospital|