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Influence of Probiotics on Prevention of Atopy, Atopic Disease and Immunological Responses

NCT00318695 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 253

Last updated 2009-01-22

No results posted yet for this study

Summary

This will be a double-blind, randomized placebo-controlled study. 253 children were recruited and randomly assigned into one of 2 groups to receive either normal infant formula or formula with Bifidobacterium longum and Lactobacillus rhamnosus GG. The primary aim is to assess the effect of early administration (from birth) of probiotics on the incidence of allergic sensitization, eczema, asthma and rhinitis.

Conditions

Interventions

DIETARY_SUPPLEMENT

Probiotics

Bifidobacterium longum \[BL999\] and Lactobacillus rhamnosus \[LPR\]

OTHER

Placebo

Commercially available cow's milk based infant formula without probiotic supplementation

Sponsors & Collaborators

  • National Medical Research Council (NMRC), Singapore

    collaborator OTHER_GOV

  • National University of Singapore

    collaborator OTHER

  • National University Hospital, Singapore

    lead OTHER

Principal Investigators

  • Dr Lynette Shek, Consultant · National University Hospital (NUH), Singapore

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-05-31
Primary Completion
2008-07-31
Completion
2009-01-31

Countries

  • Singapore

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00318695 on ClinicalTrials.gov