Influence of Probiotics on Atopy, Immunological Responses and Gut Microflora - Follow-up to 5 Years

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00365469
• Other study ID #: SQNU01 (Phase II)
• Status: Completed
• Phase: Phase 2
• First received: August 16, 2006
• Last updated: January 7, 2014
• Start date: May 2006
• Est. completion date: September 2011

Study information

• Verified date: January 2014
• Source: National University Hospital, Singapore
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Domain Specific Review Boards
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 253
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Allergic Rhinitis
• Asthma
• Eczema

Intervention

Dietary Supplement:
• Probiotic
Bifidobacterium longum [BL999] and Lactobacillus rhamnosus [LPR]

Other:
• Placebo
Commercially available cow's milk based infant formula without probiotic supplementation

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
National University Hospital, Singapore	National University, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma		5 years of age	No
Secondary	Atopic eczema		5 years of age	No
Secondary	Allergic Rhinitis		5 years of age	No
Secondary	Allergen sensitization		5 years of age	No
Secondary	Food Allergy		5 years of age	No