Trial Review

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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] 288176 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Allergic disease 1255 0
Condition category
Condition code
Inflammatory and Immune System 1341 1341 0 0
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] 1181 0
Prevention
Comparator / control treatment
The placebo contains maltodextrin alone and looks / smells like the "active" preparation.
Control group
Placebo

Outcomes
Primary outcome [1] 1827 0
Allergic sensitisation
Timepoint [1] 1827 0
At 12 months and subsequently at 2 and 5 years
Primary outcome [2] 1828 0
Allergic symptoms
Timepoint [2] 1828 0
At 12 months and subsequently at 2 and 5 years
Secondary outcome [1] 3203 0
Effects on immune function
Timepoint [1] 3203 0
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?
No
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] 1466 0
Government body
Name [1] 1466 0
NHMRC
Country [1] 1466 0
Australia
Funding source category [2] 1467 0
Commercial sector/Industry
Name [2] 1467 0
BIOXYNE LIMITED
Country [2] 1467 0
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] 1295 0
University
Name [1] 1295 0
University of Western Australia
Address [1] 1295 0
University of Western Australia
Stirling Highway, Nedlands, WA
Country [1] 1295 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2850 0
Princess Margaret Hospital
Ethics committee address [1] 2850 0
Ethics committee country [1] 2850 0
Australia
Date submitted for ethics approval [1] 2850 0
Approval date [1] 2850 0
20/09/2001
Ethics approval number [1] 2850 0
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 36211 0
Prof Susan Prescott
Address 36211 0
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: [email protected]
Country 36211 0
Australia
Phone 36211 0
+618-9340 -8171
Fax 36211 0
Email 36211 0
[email protected]
Contact person for public queries
Name 10370 0
Prof Professor Susan Prescott
Address 10370 0
School of Paediatrics and Child Health
Princess Margaret Hospital
Subiaco WA 6008
Country 10370 0
Australia
Phone 10370 0
+61 8 93408171
Fax 10370 0
+61 8 93882097
Email 10370 0
[email protected]
Contact person for scientific queries
Name 1298 0
Prof Professor Susan Prescott
Address 1298 0
School of Paediatrics and Child Health
Princess Margaret Hospital
Subiaco WA 6008
Country 1298 0
Australia
Phone 1298 0
+61 8 93408171
Fax 1298 0
+61 8 93882097
Email 1298 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseGut microbiome and innate immune response patterns in IgE-associated eczema.2015https://dx.doi.org/10.1111/cea.12566
N.B. These documents automatically identified may not have been verified by the study sponsor.