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

April 27, 2021 updated by: Christina West, Umeå University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

121

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Umeå, Sweden, SE-901 87
        • Umeå University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 months to 4 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eczema
Time Frame: 8 years of age
Eczema including related allergic manifestations
8 years of age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory allergies
Time Frame: 8 years of age
Allergic rhinitis and asthma
8 years of age
Sensitization
Time Frame: 8 years of age
Assessed by skin prick test and specific IgE tests
8 years of age
Overweight/obesity
Time Frame: 8 years of age
Assessed by BMI and DEXA-scan
8 years of age
Gut microbial composition
Time Frame: 8 years of age
Assessed by Molecular biology techniques
8 years of age
Caries
Time Frame: 8 years of age
Clinical evaluation and x-ray
8 years of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umeå University

Collaborators

Karolinska Institutet
Medical Research Council
University of Helsinki
Ekhagastiftelsen
The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)
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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2000

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

November 1, 2020

Study Registration Dates

First Submitted

May 6, 2009

First Submitted That Met QC Criteria

May 6, 2009

First Posted (Estimate)

May 7, 2009

Study Record Updates

Last Update Posted (Actual)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ELEFANT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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