Prevention Allergic Disease of Infant With Probiotics During Pregnancy and Neonatal Period
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00325273|
Recruitment Status : Completed
First Posted : May 12, 2006
Last Update Posted : March 17, 2015
|Condition or disease||Intervention/treatment||Phase|
|Atopic Dermatitis Allergic Rhinitis Asthma||Dietary Supplement: Lactobacillus rhamnosus GG||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||180 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Prevention Allergic Disease of Infant With Probiotics During Pregnancy and Neonate|
|Study Start Date :||April 2005|
|Primary Completion Date :||April 2008|
|Study Completion Date :||April 2010|
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
- Prevalence of atopic disease in infant [ Time Frame: two years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00325273
|Kaohsiung Chang Gung Memorial Hospital|
|Kaohsiung, Niao-Sung, Taiwan, 833|
|Principal Investigator:||Chia-yu Ou, MD||Chang Gung Memorial Hospital|