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

January 7, 2014 updated by: Paediatrics, National University Hospital, Singapore

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

253

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 119074
        • National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Probiotic
Commercially available cow's milk based infant formula with Bifidobacterium longum [BL999} and Lactobacillus rhamnosus [LPR]
Dietary supplement: Probiotic
Bifidobacterium longum [BL999] and Lactobacillus rhamnosus [LPR]
Placebo Comparator: Placebo
Commercially available cow's milk based infant formula without probiotic supplementation
Other: Placebo
Commercially available cow's milk based infant formula without probiotic supplementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Asthma
Time Frame: 5 years of age
5 years of age

Secondary Outcome Measures

Outcome Measure
Time Frame
Atopic eczema
Time Frame: 5 years of age
5 years of age
Allergic Rhinitis
Time Frame: 5 years of age
5 years of age
Allergen sensitization
Time Frame: 5 years of age
5 years of age
Food Allergy
Time Frame: 5 years of age
5 years of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University Hospital, Singapore

Collaborators

National University of Singapore

Investigators

  • Principal Investigator: Dr Marion Aw, Consultant, National University Hospital, Singapore
  • Principal Investigator: Dr Lynette Shek, Consultant, National University Hospital, Singapore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

August 16, 2006

First Submitted That Met QC Criteria

August 16, 2006

First Posted (Estimate)

August 17, 2006

Study Record Updates

Last Update Posted (Estimate)

January 9, 2014

Last Update Submitted That Met QC Criteria

January 7, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SQNU01 (Phase II)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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