Probiotics in Prevention of Allergies, Obesity and Caries

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-08-31

Study Completion Date

2020-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Eczema Allergy Asthma Obesity Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

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

Group Type ACTIVE_COMPARATOR

Lactobacillus F19

Intervention Type DIETARY_SUPPLEMENT

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

2

Placebo (infant cereals without any additions)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Infant cereals without any addition

Interventions

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Lactobacillus F19

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

Infant cereals without any addition

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

4 Months

Maximum Eligible Age

4 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes