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

Phase 2

Completed

• Conditions: Eczema; Asthma; Allergic Rhinitis
• Interventions: Dietary Supplement: Probiotic; Other: Placebo

• Registration Number: NCT00365469
• Lead Sponsor: National University Hospital, Singapore

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.

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-08-16
• Study First Submitted QC: 2006-08-16
• Study First Posted: 2006-08-17
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-07
• Last Update Posted: 2014-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 253

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic	Probiotic	Commercially available cow's milk based infant formula with Bifidobacterium longum \[BL999} and Lactobacillus rhamnosus \[LPR\]
Placebo	Placebo	Commercially available cow's milk based infant formula without probiotic supplementation

Primary Outcome Measures

Name	Time	Method
Asthma	5 years of age

Secondary Outcome Measures

Name	Time	Method
Atopic eczema	5 years of age
Allergic Rhinitis	5 years of age
Food Allergy	5 years of age
Allergen sensitization	5 years of age

Trial Locations

Locations (1)

National University Hospital; 🇸🇬 Singapore, Singapore