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

Prevention Allergic Disease of Infant With Probiotics During Pregnancy and Neonate

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00325273
Enrollment
180
Registered
2006-05-12
Start date
2005-04-30
Completion date
2010-04-30
Last updated
2015-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis, Allergic Rhinitis, Asthma

Keywords

Lactobacillus rhamnosus, Atopic dermatitis, Allergic rhinitis, Asthma, Infant, Pregnancy

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.

Interventions

DIETARY_SUPPLEMENTLactobacillus rhamnosus GG

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

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Prevalence of atopic disease in infanttwo years

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026