Primary Prevention of Allergic Disease in Early Child by Lactobacillus Reuteri

Summary

An altered microbial exposure may be partly responsible for the increase of allergic diseases in populations with a western lifestyle. Activation of the immune system by microbes early in life is probably required for an accurate maturation of the immune system. Probiotics, live bacteria which are considered to confer health when ingested, have been suggested to prevent eczema and sensitisation infants.

The aim of this study is to assess the effect of oral supplementation with the probiotic bacterium Lactobacillus reuteri in infancy on the development of allergic disease and sensitisation during the first 2 years of life and to examine mechanisms possibly underlying eventual effects on allergic manifestations.

A follow up was performed at 7 years of age.

Conditions

• Allergic Conditions

Interventions

DIETARY_SUPPLEMENT

Lactobacillus reuteri

The mothers started taking Lactobacillus reuteri ATCC 55730 (BioGaia AB, Stockholm, Sweden) or placebo four weeks before term and continued to do so daily until delivery. After birth, the baby commenced with the same study product as the mother at 1-3 days of age and continued daily for one year. The daily intake, five oil droplets, corresponded to 1 x 100 000 000 colony forming units (CFU)

DIETARY_SUPPLEMENT

Placebo

The placebo consists of the same oil that the active study product but without any bacteria and is not possible to differentiate from the active product by smell, taste or visual appearance

Sponsors & Collaborators

• BioGaia AB

  collaborator INDUSTRY

• The Ekhaga Foundation, Sweden

  collaborator UNKNOWN

• The Heart and Lung foundation, Sweden

  collaborator UNKNOWN

• The Research Council for the South-East Sweden

  collaborator UNKNOWN

• The Swedish Asthma and Allergy Association, Sweden

  collaborator UNKNOWN

• The Swedish Research Council

  collaborator OTHER_GOV

• University Hospital, Linkoeping

  collaborator OTHER

• Linkoeping University

  lead OTHER_GOV

Principal Investigators

• Bengt Björkstén, MD, PhD · The National Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2001-02-28

Primary Completion

2010-05-31

Completion

2010-05-31

Countries

• Sweden

Study Locations