Clinical trial NCT00325273: Prevention Allergic Disease of Infant With Probiotics During Pregnancy and Neonatal Period
Official title: Prevention Allergic Disease of Infant With Probiotics During Pregnancy and Neonate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Allergic Rhinitis
Asthma
Keywords: Lactobacillus rhamnosus
Atopic dermatitis
Allergic rhinitis
Asthma
Infant
Pregnancy
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2006-05-12
Enrollment: 180
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Prevalence of atopic disease in infant
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
state: Niao-Sung
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Chia-yu Ou, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.