NCT00894816

Probiotics in Prevention of Allergies, Obesity and Caries

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Umeå University · Academic / Other
• Sex: All
• Age: 4 Months – 4 Months
• Healthy volunteers: Accepted

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.

Conditions

• Eczema
• Allergy
• Asthma
• Obesity
• Dental Caries

Interventions

Type	Name	Description
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

Timeline

• Start date: 2000-08-01
• Primary completion: 2011-09-01
• Completion: 2020-11-01
• First posted: 2009-05-07
• Last updated: 2021-04-28

Locations

1 site across 1 country: Sweden