Effect of the Consumption of Probiotics in the Reduction of Incidence of Carious Lesions in Preschool Children

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

261 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-01-31

Brief Summary

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Probiotics are microorganisms that when administered in adequate amounts can confer health benefits. In vitro and clinical studies support the idea that lactobacilli have protective effects on oral health. A recent study in which preschoolers consumed milk drinks enriched with Lactobacillus rhamnosus, reported a reduction in caries, as well as additional benefits to children.

The aim of this study is to evaluate the effect of daily consumption of milk beverages enriched with Lactobacillus rhamnosus on the incidence of caries in preschool Chilean children.

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Detailed Description

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In this randomized controlled trial, preschool children belonging to Integra Foundation will be invited to participate. After obtaining parent´s informed consent, clinical and microbiological testing of saliva at baseline, 6 m, 12m and 18m will be performed. Differences in prevalence and incidence of caries, dmft and microbial diversity between groups will be assessed.

Conditions

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Caries Reduction Caries Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Experimental: Probiotic enriched milk

150 ml of skimmed milk enriched with probiotic (Lactobacillus rhamnosus LRH08) once a day

Group Type EXPERIMENTAL

Experimental: Probiotic enriched milk

Intervention Type DIETARY_SUPPLEMENT

Milk will be enriched with lactobacillus rhamnosus for the experimental group.

Skimmed Milk

150 ml of skimmed milk once a day

Group Type PLACEBO_COMPARATOR

Experimental: Probiotic enriched milk

Intervention Type DIETARY_SUPPLEMENT

Milk will be enriched with lactobacillus rhamnosus for the experimental group.

Interventions

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Experimental: Probiotic enriched milk

Milk will be enriched with lactobacillus rhamnosus for the experimental group.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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probiotic: Lactobacillus rhamnosus

Eligibility Criteria

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Inclusion Criteria

* Healthy children from a general health perspective, with or without cavitated carious lesions at baseline.

Exclusion Criteria

* Children with systemic disorders who need special care and / or who have intolerance to milk drinks or allergy to any of the components of the experimental and / or placebo beverage.

Minimum Eligible Age

2 Years

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No