Clinical trial NCT00365469: Influence of Probiotics on Atopy, Immunological Responses and Gut Microflora - Follow-up to 5 Years
Official title: A Follow-up Study to 5 Years of a Randomized, Double-blinded, Placebo-controlled Study on the Influence of Probiotics on Atopy, Immunological Responses and Gut Microflora
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Eczema
Asthma
Allergic Rhinitis
Keywords: Probiotics
Eczema
Asthma
Allergic Rhinitis
Prevention
Immunological responses
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
Collaborators: name: National University of Singapore
First posted: 2006-08-17
Enrollment: 253
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators had conducted a double-blind, randomized placebo-controlled clinical trial studying the effects of 6 months probiotics supplementation from birth on allergic disease and sensitization up to 2 years of age. This follow-up study will extend a further 3 years to 5 years of age for assessing the longer term beneficial effects of this form of probiotics intervention on the incidence of allergic disease and sensitization at 5 years of age.

Detailed description: Probiotics are helpful bacteria of healthy gut and have shown potential in reducing allergy. A double-blind, randomized placebo-controlled clinical trial studying the effects of 6 months probiotics supplementation from birth on allergic disease and sensitization up to 2 years of age had been conducted. This study aims to assess the longer term beneficial effects of this form of intervention on the incidence of allergic disease and sensitization at 5 years of age by extending the follow-up period.

All children (from original cohort of 253) who completed the initial 2-year visit has been invited to participate. They will be evaluated with monthly phone calls and yearly clinic visits. Allergic sensitization will be assessed with skin prick tests to a panel of allergens.

This project will provide insights into the role of early supplementation of probiotics on the development of the immune system and its effect on allergy. The additional follow-up period is critical for the evaluation of respiratory allergies in the form of clinical asthma, allergic rhinitis and sensitization to inhalant allergens, which tend to develop after 2 years of age.

Eligibility criteria: Inclusion Criteria:

* Parents agree to the subject's participation in the study and informed consent has been obtained.
* The subject has been a participant in the Phase I double-blind, randomized placebo-controlled study and had taken either normal infant formula or formula supplemented with probiotics postnatally for 6 months.
* The parents are willing to comply with study procedures and are able to keep to scheduled clinic visits.

Exclusion Criteria:

* The parent is unable /unwilling to comply with procedures.

Primary outcomes:
measure: Asthma
timeFrame: 5 years of age
Secondary outcomes:
measure: Atopic eczema
timeFrame: 5 years of age
measure: Allergic Rhinitis
timeFrame: 5 years of age
measure: Allergen sensitization
timeFrame: 5 years of age
measure: Food Allergy
timeFrame: 5 years of age
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: National University Hospital, Singapore
name: Dr Marion Aw, Consultant
role: PRINCIPAL_INVESTIGATOR
affiliation: National University Hospital, Singapore
name: Dr Lynette Shek, Consultant
role: PRINCIPAL_INVESTIGATOR
References: