Objective: To establish the effect of perinatal probiotics on the prevalence of allergic disease at the age of 5 or 6 years.
Source
Brief title
Condition
- Allergic conditions
Synonym
Research involving
Sponsors and support
Intervention
No registrations found.
Outcome measures
Primary outcome
Prevalence of the diagnosis of astma and prevalence of the diagnosis of
allergic rhinitis.
Secondary outcome
The severity of allergic astma and allergic rhinitis, as measured by lung
function testing, nitric oxide measurements in exhaled air, and specific IgE to
allergens. Other secondary endpoints are plasma and exhaled breath cytokines
and composition of gut microbiota.
Background summary
Rationale: Probiotics, if instituted early in life, can give a significant
reduction of development of eczema in infants at high risk of atopic diseases.
In 2005 a randomized controlled trial started to investigate whether probiotics
have a significant effect on the development of atopic symptoms as eczema,
allergic rhinitis, food allergy and asthma. This study population has been
followed until the age of two years. The present study is meant as a
prolongation of the former study, we will perform a follow-up study of the
included children on development of atopic symptoms.
Study objective
Objective: To establish the effect of perinatal probiotics on the prevalence of
allergic disease at the age of 5 or 6 years.
Study design
Study design: Prospective, single blind, randomised, placebo-controlled trial.
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: Parents and child are asked to fill in a
questionnaire, and pay one visit to the out patient department for physical
examination, blood sampling and pulmonary function testing with measurement of
exhaled nitric oxide. The risks of these procedures are negligible and the
burden minimal. It should be carried out specifically in these children, since
they have been included in the former study and received placebo or probiotics.
Lundlaan 6
3508 AB Utrecht
NL
Lundlaan 6
3508 AB Utrecht
NL
Listed location countries
Age
Inclusion criteria
Participation in the former study.
Exclusion criteria
No participation in the former study.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL28958.041.09 |