Probiotics in Prevention of Allergies, Obesity and Caries

Summary

During the period of 2000-2003, 179 healthy, term infants with no previous signs of allergic disease were recruited and randomized to daily intake of cereals with or without the addition of Lactobacillus paracasei subspecies paracasei strain F19 (LF19) from 4-13 months of age. The effects of LF19 on gut microbial composition, infections, allergies, immunological development, growth and blood lipids were monitored. Of 179 included infants, 171 completed the study. The study product was well tolerated with no observed side effects. Compliance was excellent.

In a follow-up study, the aim is to investigate the long-term effects of feeding LF19 during weaning on allergies, immune programming, overweight, gut microbial composition and oral health in 8-year old children.

The investigators' primary outcome will be to determine whether daily intake of LF19 during weaning results in less eczema at 8 years of age, and if the preventive effect encompasses also respiratory allergies and immunoglobulin E (IgE) - sensitization. The long term effects on gut microbial composition, overweight and metabolic markers will be investigated. Furthermore, the possible preventive effects of LF19 on caries will be assessed.

Conditions

• Eczema
• Allergy
• Asthma
• Obesity
• Dental Caries

Interventions

DIETARY_SUPPLEMENT

Lactobacillus F19

Infant cereals with the addition of Lactobacillus paracasei subsp. paracasei strain F19 (LF19)10E8 CFU per serving

DIETARY_SUPPLEMENT

Placebo

Infant cereals without any addition

Sponsors & Collaborators

• Karolinska Institutet

  collaborator OTHER

• University of Helsinki

  collaborator OTHER

• The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)

  collaborator OTHER_GOV

• Medical Research Council

  collaborator OTHER_GOV

• Ekhagastiftelsen

  collaborator OTHER

• The county of Västerbotten

  collaborator UNKNOWN

• Oskar Foundation

  collaborator OTHER

• Umeå University

  lead OTHER

Principal Investigators

• Christina E West, MD, PhD · Clinical Sciences, Pediatrics, Umeå University, SE-901 87 Umeå, Sweden

• Olle Hernell, Professor · Clinical Sciences, Pediatrics, Umeå University, SE-901 87 Umeå, Sweden

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

4 Months

Max Age

4 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2000-08-31

Primary Completion

2011-09-30

Completion

2020-11-30

Countries

• Sweden

Study Locations