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Sponsored by: |
Chang Gung Memorial Hospital |
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Information provided by: | Chang Gung Memorial Hospital |
ClinicalTrials.gov Identifier: | NCT00325273 |
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.
Condition | Intervention | Phase |
---|---|---|
Atopic Dermatitis Allergic Rhinitis Asthma |
Drug: Lactobacillus rhamnosus GG |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Prevention Allergic Disease of Infant With Probiotics During Pregnancy and Neonate |
Estimated Enrollment: | 200 |
Study Start Date: | April 2005 |
Estimated Study Completion Date: | December 2007 |
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:
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.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Chia-Yu Ou, MD | 886-7-7317123 ext 8655 | chiayu@adm.cgmh.org.rtw |
Taiwan, Niao-Sung | |
Kaohsiung Chang Gung Memorial Hospital | Recruiting |
Kaohsiung, Niao-Sung, Taiwan, 833 | |
Contact: Kuender D Yang, MD.,PHD. 886-7-7317123 kdyang@adm.cgmh.org.tw | |
Principal Investigator: Chia-Yu Ou, MD |
Principal Investigator: | Chia-yu Ou, MD | Chang Gung Memorial Hospital |
Study ID Numbers: | CMRPG84025 |
Study First Received: | May 11, 2006 |
Last Updated: | February 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00325273 |
Health Authority: | Taiwan: Department of Health |
Lactobacillus rhamnosus Atopic dermatitis Allergic rhinitis |
Asthma Infant Pregnancy |
Otorhinolaryngologic Diseases Dermatitis, Atopic Skin Diseases Asthma Rhinitis Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Infections |
Respiratory Tract Diseases Genetic Diseases, Inborn Lung Diseases Hypersensitivity, Immediate Skin Diseases, Eczematous Skin Diseases, Genetic Dermatitis Respiratory Hypersensitivity |
Immune System Diseases Bronchial Diseases Nose Diseases |