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

This study is ongoing, but not recruiting participants.
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
ClinicalTrials.gov Identifier:
NCT00894816
First received: May 6, 2009
Last updated: December 1, 2014
Last verified: December 2014
  Purpose

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 Intervention Phase
Eczema
Allergy
Asthma
Obesity
Dental Caries
Dietary Supplement: Lactobacillus F19
Dietary Supplement: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Umeå University:

Primary Outcome Measures:
  • Eczema [ Time Frame: 8 years of age ] [ Designated as safety issue: Yes ]
    Eczema including related allergic manifestations


Secondary Outcome Measures:
  • Respiratory allergies [ Time Frame: 8 years of age ] [ Designated as safety issue: Yes ]
    Allergic rhinitis and asthma

  • Sensitization [ Time Frame: 8 years of age ] [ Designated as safety issue: Yes ]
    Assessed by skin prick test and specific IgE tests

  • Overweight/obesity [ Time Frame: 8 years of age ] [ Designated as safety issue: Yes ]
    Assessed by BMI and DEXA-scan

  • Gut microbial composition [ Time Frame: 8 years of age ] [ Designated as safety issue: Yes ]
    Assessed by Molecular biology techniques

  • Caries [ Time Frame: 8 years of age ] [ Designated as safety issue: Yes ]
    Clinical evaluation and x-ray


Estimated Enrollment: 171
Study Start Date: August 2000
Estimated Study Completion Date: September 2015
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   4 Months to 4 Months
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Responsible Party: Christina West, Dr, Umeå University
ClinicalTrials.gov Identifier: NCT00894816     History of Changes
Other Study ID Numbers: ELEFANT
Study First Received: May 6, 2009
Last Updated: December 1, 2014
Health Authority: Sweden: Regional Ethical Review Board

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

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

ClinicalTrials.gov processed this record on August 02, 2015