Prevention Allergic Disease of Infant With Probiotics During Pregnancy and Neonatal Period
Primary Purpose
Atopic Dermatitis, Allergic Rhinitis, Asthma
Status
Completed
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
Lactobacillus rhamnosus GG
Sponsored by
About this trial
This is an interventional prevention trial for Atopic Dermatitis focused on measuring Lactobacillus rhamnosus, Atopic dermatitis, Allergic rhinitis, Asthma, Infant, Pregnancy
Eligibility Criteria
Inclusion Criteria: Pregnant women with atopic disease, which was determined with atopic history, elevated total IgE > 100 kU/l and positive specific IgE Exclusion Criteria: Multiple pregnancy
Sites / Locations
- Kaohsiung Chang Gung Memorial Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
probiotics & allergy
Arm Description
To understand the preventive effect of probiotics in neonatal peroid To investate the possible mechanism
Outcomes
Primary Outcome Measures
Prevalence of atopic disease in infant
Secondary Outcome Measures
Full Information
NCT ID
NCT00325273
First Posted
May 11, 2006
Last Updated
March 16, 2015
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00325273
Brief Title
Prevention Allergic Disease of Infant With Probiotics During Pregnancy and Neonatal Period
Official Title
Prevention Allergic Disease of Infant With Probiotics During Pregnancy and Neonate
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis, Allergic Rhinitis, Asthma
Keywords
Lactobacillus rhamnosus, Atopic dermatitis, Allergic rhinitis, Asthma, Infant, Pregnancy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
probiotics & allergy
Arm Type
Experimental
Arm Description
To understand the preventive effect of probiotics in neonatal peroid
To investate the possible mechanism
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus rhamnosus GG
Other Intervention Name(s)
Brand names: Culturelle DS, Culturelle HS
Intervention Description
use Lactobacillus rhamnosus GG in pregnant women from gestational 26 weeks till newborn 6 months
Primary Outcome Measure Information:
Title
Prevalence of atopic disease in infant
Time Frame
two years
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pregnant women with atopic disease, which was determined with atopic history, elevated total IgE > 100 kU/l and positive specific IgE
Exclusion Criteria:
Multiple pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chia-yu Ou, MD
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
State/Province
Niao-Sung
ZIP/Postal Code
833
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
11297958
Citation
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.
Results Reference
background
PubMed Identifier
12788576
Citation
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.
Results Reference
background
PubMed Identifier
22925325
Citation
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.
Results Reference
derived
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Prevention Allergic Disease of Infant With Probiotics During Pregnancy and Neonatal Period
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