Overview

This trial is active, not recruiting.

Conditions eczema, allergy, asthma, obesity, dental caries
Treatments lactobacillus f19, placebo
Phase phase 2/phase 3
Sponsor Umeå University
Collaborator Karolinska Institutet
Start date August 2000
End date September 2011
Trial size 171 participants
Trial identifier NCT00894816, ELEFANT

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Active Comparator)
Infant cereals with the addition of Lactobacillus paracasei subsp. paracasei strain F19 (LF19) 10E8 CFU per serving
lactobacillus f19
Infant cereals with the addition of Lactobacillus paracasei subsp. paracasei strain F19 (LF19)10E8 CFU per serving
(Placebo Comparator)
Placebo (infant cereals without any additions)
placebo
Infant cereals without any addition

Primary Outcomes

Measure
Eczema
time frame: 8 years of age

Secondary Outcomes

Measure
Respiratory allergies
time frame: 8 years of age
Sensitization
time frame: 8 years of age
Overweight/obesity
time frame: 8 years of age
Gut microbial composition
time frame: 8 years of age
Caries
time frame: 8 years of age

Eligibility Criteria

Male or female participants from 4 months up to 4 months old.

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

Additional Information

Official title Effects of Feeding Lactobacillus F19 to Infants During Weaning on Allergies, Immune Programming, Gut Microbiota, Overweight and Oral Health
Principal investigator Christina E West, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Umeå University.