Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00325273
Status:
COMPLETED
Last Update Posted:
2015-03-17
First Post:
2006-05-11
Brief Title:
Prevention Allergic Disease of Infant With Probiotics During Pregnancy and Neonatal Period
Sponsor:
Chang Gung Memorial Hospital
Organization:
Chang Gung Memorial Hospital
Study Overview
Official Title:
Prevention Allergic Disease of Infant With Probiotics During Pregnancy and Neonate
Status:
COMPLETED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 vol357 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 kUl 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 Infantchild 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
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 kUl 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 Infantchild 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None