ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12606000280505

Ethics application status

Approved

Date submitted

29/06/2006

Date registered

4/07/2006

Date last updated

16/12/2015

Type of registration

Retrospectively registered

Titles & IDs

Public title

Probiotic Allergy Prevention Study

Scientific title

The role of probiotics in the prevention of allergic disease in infancy

Secondary ID [1]

nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Allergic disease

Condition category

Condition code

Inflammatory and Immune System

Allergies

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

A randomised contriol trial: 3 billion Lactobacillus acidophilus LAVRI-A1 in maltodextrin (Probiomics, Australia) per day (or placebo) from birth to 6 months. This is given as a sachet of dried powder which is mixed with water and administered orally.

The rate of development of allergic disease will be compared between these groups at 12 months, 2 years and 5 years - as indicated below.

Intervention code [1]

Prevention

Comparator / control treatment

The placebo contains maltodextrin alone and looks / smells like the "active" preparation.

Control group

Placebo

Outcomes

Primary outcome [1]

Allergic sensitisation

Timepoint [1]

At 12 months and subsequently at 2 and 5 years

Primary outcome [2]

Allergic symptoms

Timepoint [2]

At 12 months and subsequently at 2 and 5 years

Secondary outcome [1]

Effects on immune function

Timepoint [1]

At 6 months of age.

Eligibility

Key inclusion criteria

Infants at high risk of allergic disease based on maternal allergy.

Minimum age

1 Days

Maximum age

6 Months

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Infants were ineligible for the study if their mothers smoked or had pregnancy complications including delivery prior to 37 weeks gestation.

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

allocation involved contacting the holder of the allocation schedule who was "off-site" (at Princess Margaret Hospital Pharmacy)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Block-randomisation was used and block sizes were variable to ensure that the groups were balanced for a) the type of maternal allergy (asthma versus other allergy), b) parity (first child versus two or more children), c) and paternal allergy (allergic versus non allergic).

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Phase 2

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

15/06/2002

Actual

15/06/2002

Date of last participant enrolment

Anticipated

1/06/2004

Actual

10/10/2004

Date of last data collection

Anticipated

Actual

Sample size

Target

180

Accrual to date

Final

178

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHMRC

Address [1]

GHD Building Level 1, 16 Marcus Clarke St, Canberra ACT 2601

Country [1]

Australia

Funding source category [2]

Commercial sector/Industry

Name [2]

BIOXYNE LIMITED

Address [2]

Suite 305, Level 3
35 Lime Street
Sydney NSW 2000

Country [2]

Australia

Primary sponsor type

Individual

Name

Prof Susan Prescott

Address

School of Paediatrics and Child Health
University of Western Australia
Princess Margaret Hospital for Children
GPO Box D 184 Perth, WA, 6840
Australia

Country

Australia

Secondary sponsor category [1]

University

Name [1]

University of Western Australia

Address [1]

University of Western Australia
Stirling Highway, Nedlands, WA

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Princess Margaret Hospital

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

20/09/2001

Ethics approval number [1]

636/EP

Summary

Brief summary

To aim of this study is to investigate the effects of probiotic supplementation for the first 6 months of life in infants at high risk of allergic disease. The study has been designed to determine if this intervention reduces the risk of developing allergic sensitisation (determined by allergy skin testing) and allergic disease (such as food allergy, atopic dermatitis and asthma) in early childhood. The participants and investigators remained blind to the intervention throughout the follow up period.

Trial website

Trial related presentations / publications

Taylor A, Dunstan J, Prescott SL. Probiotic supplementation for the first 6 months of life fails to reduce the risk of atopic dermatitis and increases the risk of allergen sensitisation in high risk children: a randomised controlled trial. J Allergy Clin Immunology 2007 119(1):184-91. 

M Jensen, S Meldrum, AL Taylor, JA Dunstan, SL Prescott. Early probiotic supplementation for allergy prevention: long term outcomes Journal Allergy Clin Immunol 2012; 130(5):1209-1211.

Taylor A, Hale J, Hole J, Lehmann H, Dunstan J, Prescott SL. The effects of probiotic supplementation from the neonatal period on innate immune development in infancy. Clin Exp Allergy 2006 ;36: 1218–1226. 

Taylor A, Hale J, Wiltschut J, Lehmann H, Dunstan J, Prescott SL. The effects of probiotic supplementation for the first 6 months of life on allergen and vaccine specific immune responses. Clin Exp Allergy 2006; 36:1227-1235.

Public notes

Contacts

Principal investigator

Name

Prof Susan Prescott

Address

Professor and Paediatric Allergist and Immunologist
School of Paediatrics and Child Health
University of Western Australia
Princess Margaret Hospital for Children
GPO Box D 184 Perth, WA, 6840
Australia
tel: +618-9340 -8171
fax: +618 9388 2097
email: susan.prescott@uwa.edu.au

Country

Australia

Phone

+618-9340 -8171

Fax

susan.prescott@uwa.edu.au

Contact person for public queries

Name

Professor Susan Prescott

Address

School of Paediatrics and Child Health
Princess Margaret Hospital
Subiaco WA 6008

Country

Australia

Phone

+61 8 93408171

Fax

+61 8 93882097

susanp@ichr.uwa.edu.au

Contact person for scientific queries

Name

Professor Susan Prescott

Address

School of Paediatrics and Child Health
Princess Margaret Hospital
Subiaco WA 6008

Country

Australia

Phone

+61 8 93408171

Fax

+61 8 93882097

susanp@ichr.uwa.edu.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Gut microbiome and innate immune response patterns in IgE-associated eczema.	2015	https://dx.doi.org/10.1111/cea.12566

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically