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Probiotics in Prevention of Allergies, Obesity and Caries (ELEFANT)

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ClinicalTrials.gov Identifier: NCT00894816
Recruitment Status : Active, not recruiting
First Posted : May 7, 2009
Last Update Posted : October 25, 2017
Sponsor:
Collaborators:
Karolinska Institutet
Helsinki University
The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)
Medical Research Council
Ekhagastiftelsen
The county of Västerbotten
Oskar Foundation
Information provided by (Responsible Party):
Christina West, Umeå University

Brief 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.


Condition or disease Intervention/treatment Phase
Eczema Allergy Asthma Obesity Dental Caries Dietary Supplement: Lactobacillus F19 Dietary Supplement: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 171 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Feeding Lactobacillus F19 to Infants During Weaning on Allergies, Immune Programming, Gut Microbiota, Overweight and Oral Health
Study Start Date : August 2000
Actual Primary Completion Date : September 2011
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Eczema
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Infant cereals with the addition of Lactobacillus paracasei subsp. paracasei strain F19 (LF19) 10E8 CFU per serving
Dietary Supplement: Lactobacillus F19
Infant cereals with the addition of Lactobacillus paracasei subsp. paracasei strain F19 (LF19)10E8 CFU per serving
Placebo Comparator: 2
Placebo (infant cereals without any additions)
Dietary Supplement: Placebo
Infant cereals without any addition



Primary Outcome Measures :
  1. Eczema [ Time Frame: 8 years of age ]
    Eczema including related allergic manifestations


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   4 Months to 4 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00894816


Locations
Sweden
Umeå University
Umeå, Sweden, SE-901 87
Sponsors and Collaborators
Umeå University
Karolinska Institutet
Helsinki University
The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)
Medical Research Council
Ekhagastiftelsen
The county of Västerbotten
Oskar Foundation
Investigators
Principal Investigator: Christina E West, MD, PhD Clinical Sciences, Pediatrics, Umeå University, SE-901 87 Umeå, Sweden
Study Chair: Olle Hernell, Professor Clinical Sciences, Pediatrics, Umeå University, SE-901 87 Umeå, Sweden

Publications of Results:
Other Publications:
Responsible Party: Christina West, Dr, Umeå University
ClinicalTrials.gov Identifier: NCT00894816     History of Changes
Other Study ID Numbers: ELEFANT
First Posted: May 7, 2009    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017

Keywords provided by Christina West, Umeå University:
Prevention
Probiotics
Eczema
Allergy
Asthma
Obesity
Caries
Gut microbiota

Additional relevant MeSH terms:
Obesity
Hypersensitivity
Dental Caries
Eczema
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Immune System Diseases
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Dermatitis
Skin Diseases
Skin Diseases, Eczematous