Probiotics in Prevention of Allergies, Obesity and Caries (ELEFANT)
Primary Purpose
Eczema, Allergy, Asthma
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Lactobacillus F19
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Eczema focused on measuring Prevention, Probiotics, Eczema, Allergy, Asthma, Obesity, Caries, Gut microbiota
Eligibility 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
Sites / Locations
- Umeå University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Infant cereals with the addition of Lactobacillus paracasei subsp. paracasei strain F19 (LF19) 10E8 CFU per serving
Placebo (infant cereals without any additions)
Outcomes
Primary Outcome Measures
Eczema
Eczema including related allergic manifestations
Secondary Outcome Measures
Respiratory allergies
Allergic rhinitis and asthma
Sensitization
Assessed by skin prick test and specific IgE tests
Overweight/obesity
Assessed by BMI and DEXA-scan
Gut microbial composition
Assessed by Molecular biology techniques
Caries
Clinical evaluation and x-ray
Full Information
NCT ID
NCT00894816
First Posted
May 6, 2009
Last Updated
April 27, 2021
Sponsor
Umeå University
Collaborators
Karolinska Institutet, University of Helsinki, The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS), Medical Research Council, Ekhagastiftelsen, The county of Västerbotten, Oskar Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00894816
Brief Title
Probiotics in Prevention of Allergies, Obesity and Caries
Acronym
ELEFANT
Official Title
Effects of Feeding Lactobacillus F19 to Infants During Weaning on Allergies, Immune Programming, Gut Microbiota, Overweight and Oral Health
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
August 2000 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
November 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Umeå University
Collaborators
Karolinska Institutet, University of Helsinki, The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS), Medical Research Council, Ekhagastiftelsen, The county of Västerbotten, Oskar Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eczema, Allergy, Asthma, Obesity, Dental Caries
Keywords
Prevention, Probiotics, Eczema, Allergy, Asthma, Obesity, Caries, Gut microbiota
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
121 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Infant cereals with the addition of Lactobacillus paracasei subsp. paracasei strain F19 (LF19) 10E8 CFU per serving
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo (infant cereals without any additions)
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus F19
Intervention Description
Infant cereals with the addition of Lactobacillus paracasei subsp. paracasei strain F19 (LF19)10E8 CFU per serving
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Infant cereals without any addition
Primary Outcome Measure Information:
Title
Eczema
Description
Eczema including related allergic manifestations
Time Frame
8 years of age
Secondary Outcome Measure Information:
Title
Respiratory allergies
Description
Allergic rhinitis and asthma
Time Frame
8 years of age
Title
Sensitization
Description
Assessed by skin prick test and specific IgE tests
Time Frame
8 years of age
Title
Overweight/obesity
Description
Assessed by BMI and DEXA-scan
Time Frame
8 years of age
Title
Gut microbial composition
Description
Assessed by Molecular biology techniques
Time Frame
8 years of age
Title
Caries
Description
Clinical evaluation and x-ray
Time Frame
8 years of age
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Months
Maximum Age & Unit of Time
4 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina E West, MD, PhD
Organizational Affiliation
Clinical Sciences, Pediatrics, Umeå University, SE-901 87 Umeå, Sweden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Olle Hernell, Professor
Organizational Affiliation
Clinical Sciences, Pediatrics, Umeå University, SE-901 87 Umeå, Sweden
Official's Role
Study Chair
Facility Information:
Facility Name
Umeå University
City
Umeå
ZIP/Postal Code
SE-901 87
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
24830782
Citation
Karlsson Videhult F, Ohlund I, Stenlund H, Hernell O, West CE. Probiotics during weaning: a follow-up study on effects on body composition and metabolic markers at school age. Eur J Nutr. 2015 Apr;54(3):355-63. doi: 10.1007/s00394-014-0715-y. Epub 2014 May 17.
Results Reference
background
PubMed Identifier
18086218
Citation
West CE, Gothefors L, Granstrom M, Kayhty H, Hammarstrom ML, Hernell O. Effects of feeding probiotics during weaning on infections and antibody responses to diphtheria, tetanus and Hib vaccines. Pediatr Allergy Immunol. 2008 Feb;19(1):53-60. doi: 10.1111/j.1399-3038.2007.00583.x. Epub 2007 Dec 11.
Results Reference
result
PubMed Identifier
19298231
Citation
West CE, Hammarstrom ML, Hernell O. Probiotics during weaning reduce the incidence of eczema. Pediatr Allergy Immunol. 2009 Aug;20(5):430-7. doi: 10.1111/j.1399-3038.2009.00745.x. Epub 2009 Mar 9.
Results Reference
result
PubMed Identifier
22417212
Citation
West CE, Hernell O, Andersson Y, Sjostedt M, Hammarstrom ML. Probiotic effects on T-cell maturation in infants during weaning. Clin Exp Allergy. 2012 Apr;42(4):540-9. doi: 10.1111/j.1365-2222.2011.03941.x.
Results Reference
result
PubMed Identifier
23895631
Citation
West CE, Hammarstrom ML, Hernell O. Probiotics in primary prevention of allergic disease--follow-up at 8-9 years of age. Allergy. 2013 Aug;68(8):1015-20. doi: 10.1111/all.12191. Epub 2013 Jul 30.
Results Reference
result
PubMed Identifier
23838478
Citation
Hasslof P, West CE, Videhult FK, Brandelius C, Stecksen-Blicks C. Early intervention with probiotic Lactobacillus paracasei F19 has no long-term effect on caries experience. Caries Res. 2013;47(6):559-65. doi: 10.1159/000350524. Epub 2013 Jul 4.
Results Reference
result
Learn more about this trial
Probiotics in Prevention of Allergies, Obesity and Caries
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