Trial | NCT00894816  Report issue

Title

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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    121
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.
Study Started
Aug 31
2000
Primary Completion
Sep 30
2011
Study Completion
Nov 30
2020
Last Update
Apr 28
2021

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

1 Active Comparator

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

2 Placebo Comparator

Placebo (infant cereals without any additions)

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
No Results Posted