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

Phase 3

Completed

• Conditions: Atopic Dermatitis; Asthma; Allergic Rhinitis
• Interventions: Dietary Supplement: Lactobacillus rhamnosus GG

• Registration Number: NCT00325273
• Lead Sponsor: Chang Gung Memorial Hospital

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:

1. Inclusion criteria: Pregnant women with atopic disease, which was determined with atopic history, elevated total IgE \> 100 kU/l 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: 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 Timeline

• Study Start: 2005-04
• Study First Submitted: 2006-05-11
• Study First Submitted QC: 2006-05-11
• Study First Posted: 2006-05-12
• Primary Completion: 2008-04
• Study Completion: 2010-04
• Status Verified: 2011-06
• Last Update Submitted: 2015-03-16
• Last Update Posted: 2015-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
probiotics & allergy	Lactobacillus rhamnosus GG	1. To understand the preventive effect of probiotics in neonatal peroid 2. To investate the possible mechanism

Primary Outcome Measures

Name	Time	Method
Prevalence of atopic disease in infant	two years

Trial Locations

Locations (1)

Kaohsiung Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Niao-Sung, Taiwan