Influence of Probiotics on Atopy, Immunological Responses... | NCT00365469

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

NCT00365469

Sponsor

National University Hospital, Singapore

Status

Completed

Last Update Posted

Jan 9, 2014Estimated

Enrollment

253Actual

Phase

Phase 2

Conditions

Eczema
Asthma
Allergic Rhinitis

Interventions

Probiotic
Placebo

Countries

Singapore

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2006

Primary Completion Date

Sep 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

Aug 16, 2006

First Submission Date that Met QC Criteria

Aug 16, 2006

First Posted Date

Aug 17, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 7, 2014

Last Update Posted Date

Jan 9, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Paediatrics, Dr Marion Aw, National University Hospital, SingaporePrincipal Investigator

Lead Sponsor

National University Hospital, SingaporeOTHER

Collaborators

Name	Class
National University of Singapore	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

253Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Probiotic	Experimental	Commercially available cow's milk based infant formula with Bifidobacterium longum [BL999} and Lactobacillus rhamnosus [LPR]](streamdown:incomplete-link)	Dietary Supplement: Probiotic
Placebo	Placebo Comparator	Commercially available cow's milk based infant formula without probiotic supplementation	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Probiotic	Dietary Supplement	Bifidobacterium longum [BL999] and Lactobacillus rhamnosus [LPR]	Probiotic

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Asthma		5 years of age

Secondary Outcomes

Measure	Description	Time Frame
Atopic eczema		5 years of age
Allergic Rhinitis		5 years of age
Allergen sensitization

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dr Marion Aw, Consultant	National University Hospital, Singapore	Principal Investigator
Dr Lynette Shek, Consultant	National University Hospital, Singapore	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National University Hospital		Singapore		119074	Singapore

Condition Browse Module

MeSH Terms

ID	Term
D004485	Eczema
D001249	Asthma
D065631	Rhinitis, Allergic

Ancestor Terms

ID	Term
D003872	Dermatitis
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D017443	Skin Diseases, Eczematous

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019936	Probiotics

Ancestor Terms

ID	Term
D019587	Dietary Supplements
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided