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

Primary Purpose

Eczema, Asthma, Allergic Rhinitis

Status
Completed
Phase
Phase 2
Locations
Singapore
Study Type
Interventional
Intervention
Probiotic
Placebo
Sponsored by
National University Hospital, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Eczema focused on measuring Probiotics, Eczema, Asthma, Allergic Rhinitis, Prevention, Immunological responses

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Probiotic

Placebo

Arm Description

Commercially available cow's milk based infant formula with Bifidobacterium longum [BL999} and Lactobacillus rhamnosus [LPR]

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

Outcomes

Primary Outcome Measures

Asthma

Secondary Outcome Measures

Atopic eczema
Allergic Rhinitis
Allergen sensitization
Food Allergy

Full Information

First Posted
August 16, 2006
Last Updated
January 7, 2014
Sponsor
National University Hospital, Singapore
Collaborators
National University of Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT00365469
Brief Title
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

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University Hospital, Singapore
Collaborators
National University of Singapore

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eczema, Asthma, Allergic Rhinitis
Keywords
Probiotics, Eczema, Asthma, Allergic Rhinitis, Prevention, Immunological responses

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
253 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Probiotic
Arm Type
Experimental
Arm Description
Commercially available cow's milk based infant formula with Bifidobacterium longum [BL999} and Lactobacillus rhamnosus [LPR]
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Commercially available cow's milk based infant formula without probiotic supplementation
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic
Intervention Description
Bifidobacterium longum [BL999] and Lactobacillus rhamnosus [LPR]
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Commercially available cow's milk based infant formula without probiotic supplementation
Primary Outcome Measure Information:
Title
Asthma
Time Frame
5 years of age
Secondary Outcome Measure Information:
Title
Atopic eczema
Time Frame
5 years of age
Title
Allergic Rhinitis
Time Frame
5 years of age
Title
Allergen sensitization
Time Frame
5 years of age
Title
Food Allergy
Time Frame
5 years of age

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Marion Aw, Consultant
Organizational Affiliation
National University Hospital, Singapore
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr Lynette Shek, Consultant
Organizational Affiliation
National University Hospital, Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore

12. IPD Sharing Statement

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

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