Probiotics in Prevention of Allergies, Obesity and Caries

Obesity Clinical Trial

— ELEFANT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00894816
• Other study ID #: ELEFANT
• Status: Completed
• Phase: N/A
• Start date: August 2000
• Est. completion date: November 2020

Study information

• Verified date: April 2021
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: November 2020
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Months to 4 Months

Eligibility

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

Related Conditions & MeSH terms

• Allergy
• Asthma
• Dental Caries
• Eczema
• Hypersensitivity
• Obesity

Intervention

Dietary Supplement:
• Lactobacillus F19
Infant cereals with the addition of Lactobacillus paracasei subsp. paracasei strain F19 (LF19)10E8 CFU per serving
• Placebo
Infant cereals without any addition

Locations

Country	Name	City	State
Sweden	Umeå University	Umeå

Sponsors (8)

Lead Sponsor	Collaborator
Umeå University	Ekhagastiftelsen, Karolinska Institutet, Medical Research Council, Oskar Foundation, The county of Västerbotten, The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS), University of Helsinki

Country where clinical trial is conducted

Sweden, 

References & Publications (6)

Hasslöf P, West CE, Videhult FK, Brandelius C, Stecksén-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. — View Citation

Karlsson Videhult F, Öhlund 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. — View Citation

West CE, Gothefors L, Granström M, Käyhty H, Hammarström 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. Epub 2007 Dec — View Citation

West CE, Hammarström 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. — View Citation

West CE, Hammarström 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. — View Citation

West CE, Hernell O, Andersson Y, Sjöstedt M, Hammarström 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eczema	Eczema including related allergic manifestations	8 years of age
Secondary	Respiratory allergies	Allergic rhinitis and asthma	8 years of age
Secondary	Sensitization	Assessed by skin prick test and specific IgE tests	8 years of age
Secondary	Overweight/obesity	Assessed by BMI and DEXA-scan	8 years of age
Secondary	Gut microbial composition	Assessed by Molecular biology techniques	8 years of age
Secondary	Caries	Clinical evaluation and x-ray	8 years of age