Probiotic Allergy Prevention Study

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000280505

Enrollment

178

Registered

2006-07-04

Start date

2002-06-15

Completion date

2004-10-10

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Single group

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

1 Days to 6 Months

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Outcome results