Clinical trial NCT00894816: Probiotics in Prevention of Allergies, Obesity and Caries
Official title: Effects of Feeding Lactobacillus F19 to Infants During Weaning on Allergies, Immune Programming, Gut Microbiota, Overweight and Oral Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eczema
Allergy
Asthma
Obesity
Dental Caries
Keywords: Prevention
Probiotics
Eczema
Allergy
Asthma
Obesity
Caries
Gut microbiota
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
name: University of Helsinki
name: The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)
name: Medical Research Council
name: Ekhagastiftelsen
name: The county of Västerbotten
name: Oskar Foundation
First posted: 2009-05-07
Enrollment: 121
Sex: ALL
Minimum age (years): 4
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Eczema
timeFrame: 8 years of age
Secondary outcomes:
measure: Respiratory allergies
timeFrame: 8 years of age
measure: Sensitization
timeFrame: 8 years of age
measure: Overweight/obesity
timeFrame: 8 years of age
measure: Gut microbial composition
timeFrame: 8 years of age
measure: Caries
timeFrame: 8 years of age
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Umeå University
Study officials:
affiliation: Clinical Sciences, Pediatrics, Umeå University, SE-901 87 Umeå, Sweden
name: Christina E West, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Sciences, Pediatrics, Umeå University, SE-901 87 Umeå, Sweden
name: Olle Hernell, Professor
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.
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.