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Completed

NCT Number: NCT00894816

Probiotics in Prevention of Allergies, Obesity and Caries

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.

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Key information

Conditions

Eczema Allergy Asthma Body Weight Bronchial Diseases Dental Caries Dermatitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Respiratory Hypersensitivity Respiratory Tract Diseases Signs and Symptoms Skin Diseases Skin Diseases, Eczematous Skin and Connective Tissue Diseases Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

4 month–4 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Umeå University

Umeå, SE-901 87, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy infants born at term (gestational age 37-42 weeks)
  • Birth weight > 2500 g
  • Vaginally delivered
  • No atopic manifestation
  • A normal diet for age
  • No medication that could have affected the intestinal microbiota

Treatment and study plan

Lactobacillus F19

Dietary Supplement

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

Placebo

Dietary Supplement

Infant cereals without any addition

Primary outcomes

  1. Eczema

    Time frame: 8 years of age

    Eczema including related allergic manifestations

Secondary outcomes

  1. Respiratory allergies

    Time frame: 8 years of age

    Allergic rhinitis and asthma

  2. Sensitization

    Time frame: 8 years of age

    Assessed by skin prick test and specific IgE tests

  3. Overweight/obesity

    Time frame: 8 years of age

    Assessed by BMI and DEXA-scan

  4. Gut microbial composition

    Time frame: 8 years of age

    Assessed by Molecular biology techniques

  5. Caries

    Time frame: 8 years of age

    Clinical evaluation and x-ray

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Collaborators

  • Ekhagastiftelsen
  • Karolinska Institutet
  • Medical Research Council
  • Oskar Foundation
  • The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)
  • The county of Västerbotten
  • University of Helsinki

Registry information

Official study title

Effects of Feeding Lactobacillus F19 to Infants During Weaning on Allergies, Immune Programming, Gut Microbiota, Overweight and Oral Health

Acronym: ELEFANT

Important dates

Study start
2000
Primary completion
2011
Study completion
2020
First posted
May 7, 2009
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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