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

Seventh Frame Work Programme (European Commission)

Information provided by (Responsible Party):

Christina West, Umeå University

ClinicalTrials.gov Identifier:

NCT00894816

First received: May 6, 2009

Last updated: June 19, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

May 6, 2009

Last Updated Date

June 19, 2012

Start Date ^ICMJE

August 2000

Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Eczema [ Time Frame: 8 years of age ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00894816 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Respiratory allergies [ Time Frame: 8 years of age ] [ Designated as safety issue: Yes ]
Sensitization [ Time Frame: 8 years of age ] [ Designated as safety issue: Yes ]
Overweight/obesity [ Time Frame: 8 years of age ] [ Designated as safety issue: Yes ]
Gut microbial composition [ Time Frame: 8 years of age ] [ Designated as safety issue: Yes ]
Caries [ Time Frame: 8 years of age ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Probiotics in Prevention of Allergies, Obesity and Caries

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Condition ^ICMJE

Eczema
Allergy
Asthma
Obesity
Dental Caries

Intervention ^ICMJE

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

Study Arm (s)

Active Comparator: 1
Infant cereals with the addition of Lactobacillus paracasei subsp. paracasei strain F19 (LF19) 10E8 CFU per serving

Intervention: Dietary Supplement: Lactobacillus F19
Placebo Comparator: 2
Placebo (infant cereals without any additions)

Intervention: Dietary Supplement: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

171

Estimated Completion Date

September 2013

Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

4 Months to 4 Months

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Sweden

Administrative Information

NCT Number ^ICMJE

NCT00894816

Other Study ID Numbers ^ICMJE

ELEFANT

Has Data Monitoring Committee

Responsible Party

Christina West, Umeå University

Study Sponsor ^ICMJE

Umeå University

Collaborators ^ICMJE

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
Seventh Frame Work Programme (European Commission)

Investigators ^ICMJE

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

Information Provided By

Umeå University

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top