Prevention Allergic Disease of Infant With Probiotics During Pregnancy and Neonatal Period

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.

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Key information

Conditions

Atopic Dermatitis Allergic Rhinitis Asthma Bronchial Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Niao-Sung, 833, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lactobacillus rhamnosus GG

Dietary Supplement

use Lactobacillus rhamnosus GG in pregnant women from gestational 26 weeks till newborn 6 months

Other names: Brand names: Culturelle DS, Culturelle HS

Primary outcomes

Prevalence of atopic disease in infant

Time frame: two years

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

Prevention Allergic Disease of Infant With Probiotics During Pregnancy and Neonate

Important dates

Study start: 2005
Primary completion: 2008
Study completion: 2010
First posted: May 12, 2006
Registry last updated: Mar 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed