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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00894816

Acronym

ELEFANT

Enrollment

121

Registered

2009-05-07

Start date

2000-08-31

Completion date

2020-11-30

Last updated

2021-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergy, Asthma, Dental Caries, Eczema, Obesity

Keywords

Prevention, Probiotics, Eczema, Allergy, Asthma, Obesity, Caries, Gut microbiota

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.

Interventions

DIETARY_SUPPLEMENTLactobacillus F19

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

DIETARY_SUPPLEMENTPlacebo

Infant cereals without any addition

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

4 Months to 4 Months

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Eczema	8 years of age	Eczema including related allergic manifestations

Secondary

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

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026