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

Asthma Clinical Trial

Official title:

Prevention Allergic Disease of Infant With Probiotics During Pregnancy and Neonate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00325273
• Other study ID #: CMRPG84025
• Status: Completed
• Phase: Phase 3
• First received: May 11, 2006
• Last updated: March 16, 2015
• Start date: April 2005
• Est. completion date: April 2010

Study information

• Verified date: June 2011
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: April 2010
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Allergic Rhinitis
• Asthma
• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Dietary Supplement:
• Lactobacillus rhamnosus GG
use Lactobacillus rhamnosus GG in pregnant women from gestational 26 weeks till newborn 6 months

Locations

Country	Name	City	State
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung	Niao-Sung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

Kalliomäki 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. — View Citation

Kalliomäki 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of atopic disease in infant		two years	No