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

NCT00325273 | Completed Phase 3 DMC

• 1 other identifier: CMRPG84025
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis; Allergic Rhinitis; Asthma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Prevalence of atopic disease in infant

  two years

Study Arms (1)

probiotics & allergy

EXPERIMENTAL

1. To understand the preventive effect of probiotics in neonatal peroid 2. To investate the possible mechanism

Dietary Supplement: Lactobacillus rhamnosus GG

Interventions

Lactobacillus rhamnosus GG DIETARY_SUPPLEMENT

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

Also known as: Brand names: Culturelle DS, Culturelle HS

probiotics & allergy

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women with atopic disease, which was determined with atopic history, elevated total IgE \> 100 kU/l and positive specific IgE

You may not qualify if:

• Multiple pregnancy

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Niao-Sung, 833, Taiwan

Location

Related Publications (3)

• Kalliomaki M, Salminen S, Arvilommi H, Kero P, Koskinen P, Isolauri E. Probiotics in primary prevention of atopic disease: a randomised placebo-controlled trial. Lancet. 2001 Apr 7;357(9262):1076-9. doi: 10.1016/S0140-6736(00)04259-8.

  PMID: 11297958 BACKGROUND

• Kalliomaki M, Salminen S, Poussa T, Arvilommi H, Isolauri E. Probiotics and prevention of atopic disease: 4-year follow-up of a randomised placebo-controlled trial. Lancet. 2003 May 31;361(9372):1869-71. doi: 10.1016/S0140-6736(03)13490-3.

  PMID: 12788576 BACKGROUND

• Ou CY, Kuo HC, Wang L, Hsu TY, Chuang H, Liu CA, Chang JC, Yu HR, Yang KD. Prenatal and postnatal probiotics reduces maternal but not childhood allergic diseases: a randomized, double-blind, placebo-controlled trial. Clin Exp Allergy. 2012 Sep;42(9):1386-96. doi: 10.1111/j.1365-2222.2012.04037.x.

  PMID: 22925325 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic; Rhinitis, Allergic; Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

• Chia-yu Ou, MD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 11, 2006
• First Posted: May 12, 2006
• Study Start: April 1, 2005
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2010
• Last Updated: March 17, 2015

Record last verified: 2011-06

Locations

TW (1)