Allergic Asthma Clinical Trial
— FRALACOfficial title:
Efficacy of Lactbacillus GG on Wheeze and Allergic Sensitization in Infants at Risk
Given that asthma results from a complex interaction between genetic susceptibility and environmental factors and rates of childhood asthma are increasing, primary prevention has to focus on modifiable aspects such as nutrition. There a implications from epidemiology that food supplementation with probiotics given to atopic mothers in pregnancy and during lactation can prevent the development allergies in the offspring. Children with atopic dermatitis are at increased risk (up to 80%) of developing persistent respiratory tract disease. Our trial examined whether probiotics are able to prevent allergic sensitization and allergic asthma when given to 6-24 month old infants at an increased risk of allergies.
Status | Completed |
Enrollment | 131 |
Est. completion date | October 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Months to 24 Months |
Eligibility |
Inclusion Criteria: - History of at least 3 episodes of wheezing bronchitis, - First degree relative with history of allergic disease Exclusion Criteria: - Congenital malformations, - Immunologic or oncologic systemic disorders, - Current antibiotic therapy, - Prior exposure to probiotics; and - Known intolerances towards ingredients of the probiotics (LGG, microcristalline cellulose, gelatine, magnesiumstearate, titandioxide). |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Germany | Childrens' Hospital, Goethe University | Frankfurt | Hessen |
Lead Sponsor | Collaborator |
---|---|
Johann Wolfgang Goethe University Hospitals |
Germany,
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
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | episodes of wheezing, drug use (inhalative steroids and betamimetics), hospital treatment | October 2002 - October 2004 | ||
Secondary | allergic sensitization, levels of IgE, inflammatory mediators, SCORAD indices | October 2002-October 2004 |
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