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

This study has been completed.
Sponsor:
Information provided by:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00325273
First received: May 11, 2006
Last updated: March 16, 2015
Last verified: June 2011
  Purpose

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
Dietary Supplement: Lactobacillus rhamnosus GG
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Prevention Allergic Disease of Infant With Probiotics During Pregnancy and Neonate

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • Prevalence of atopic disease in infant [ Time Frame: two years ] [ Designated as safety issue: No ]

Enrollment: 180
Study Start Date: April 2005
Study Completion Date: April 2010
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: probiotics & allergy
  1. To understand the preventive effect of probiotics in neonatal peroid
  2. To investate the possible mechanism
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

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.
  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00325273

Locations
Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung, Niao-Sung, Taiwan, 833
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Chia-yu Ou, MD Chang Gung Memorial Hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chiayu Ou/chief in department of Obstetrics, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT00325273     History of Changes
Other Study ID Numbers: CMRPG84025
Study First Received: May 11, 2006
Last Updated: March 16, 2015
Health Authority: Taiwan: Department of Health

Keywords provided by Chang Gung Memorial Hospital:
Lactobacillus rhamnosus
Atopic dermatitis
Allergic rhinitis
Asthma
Infant
Pregnancy

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Genetic Diseases, Inborn
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic

ClinicalTrials.gov processed this record on July 30, 2015