Prevention Allergic Disease of Infant With Probiotics During Pregnancy and Neonatal Period
NCT ID: NCT00325273
Last Updated: 2015-03-17
Study Results
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Basic Information
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COMPLETED
PHASE3
180 participants
INTERVENTIONAL
2005-04-30
2010-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
TRIPLE
Study Groups
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probiotics & allergy
1. To understand the preventive effect of probiotics in neonatal peroid
2. To investate the possible mechanism
Lactobacillus rhamnosus GG
use Lactobacillus rhamnosus GG in pregnant women from gestational 26 weeks till newborn 6 months
Interventions
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Lactobacillus rhamnosus GG
use Lactobacillus rhamnosus GG in pregnant women from gestational 26 weeks till newborn 6 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
FEMALE
No
Sponsors
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Chang Gung Memorial Hospital
OTHER
Responsible Party
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Chang Gung Memorial Hospital
Principal Investigators
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Chia-yu Ou, MD
Role: PRINCIPAL_INVESTIGATOR
Chang Gung Memorial Hospital
Locations
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Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Niao-Sung, Taiwan
Countries
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References
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Kalliomaki M, Salminen S, Arvilommi H, Kero P, Koskinen P, Isolauri E. Probiotics in primary prevention of atopic disease: a randomised placebo-controlled trial. Lancet. 2001 Apr 7;357(9262):1076-9. doi: 10.1016/S0140-6736(00)04259-8.
Kalliomaki M, Salminen S, Poussa T, Arvilommi H, Isolauri E. Probiotics and prevention of atopic disease: 4-year follow-up of a randomised placebo-controlled trial. Lancet. 2003 May 31;361(9372):1869-71. doi: 10.1016/S0140-6736(03)13490-3.
Ou CY, Kuo HC, Wang L, Hsu TY, Chuang H, Liu CA, Chang JC, Yu HR, Yang KD. Prenatal and postnatal probiotics reduces maternal but not childhood allergic diseases: a randomized, double-blind, placebo-controlled trial. Clin Exp Allergy. 2012 Sep;42(9):1386-96. doi: 10.1111/j.1365-2222.2012.04037.x.
Other Identifiers
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CMRPG84025
Identifier Type: -
Identifier Source: org_study_id
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