Probiotics in Prevention of Allergies, Obesity and Caries

Not Applicable

Completed

• Conditions: Asthma; Dental Caries; Allergy; Obesity; Eczema
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Lactobacillus F19

• Registration Number: NCT00894816
• Lead Sponsor: Umeå University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-08
• Study First Submitted: 2009-05-06
• Study First Submitted QC: 2009-05-06
• Study First Posted: 2009-05-07
• Primary Completion: 2011-09
• Study Completion: 2020-11
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	Placebo (infant cereals without any additions)
1	Lactobacillus F19	Infant cereals with the addition of Lactobacillus paracasei subsp. paracasei strain F19 (LF19) 10E8 CFU per serving

Primary Outcome Measures

Name	Time	Method
Eczema	8 years of age	Eczema including related allergic manifestations

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Umeå University; 🇸🇪 Umeå, Sweden