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Effects of a food enriched with probiotics based Lactobacillus rhamnosus GG on the count of Streptococcus mutans and Lactobacillus sp and the presence of incipient caries in children 3 to 4 years in Cali, Colombia

Effects of a food enriched with probiotics based Lactobacillus rhamnosus GG on the count of Streptococcus mutans and Lactobacillus sp and the presence of incipient caries in children 3 to 4 years in Cali, Colombia

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616001363471
Acronym
none
Enrollment
363
Registered
2016-09-30
Start date
2016-10-15
Completion date
2017-07-14
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

Dental caries is a disease that can occur during any stage of the life cycle, as a result of the imbalance in the ore the tooth surface, product of the metabolism of microorganisms, acidifying more the environment, contributing to the dynamic degradation of enamel. 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. Some studies have shown a reduction in the count of cariogenic microorganisms with Streptococcus mutans when you consume probiotics containing Lactobacillus rhamnosus GG. 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 in the city Cali, Colombia.

Interventions

A total number of 360 children were cluster randomized assigned to two groups: children in the intervention group were served milk supplemented with probiotic and the control group received standard milk. The children will be examined at baseline, the pH in saliva will be taken, samples of saliva, plaque index. Their teeth will be brush and them make the evaluation of dental caries with the International Caries Detection and Assessment System (ICDAS). It will start the supply of milk with prob

A total number of 360 children were cluster randomized assigned to two groups: children in the intervention group were served milk supplemented with probiotic and the control group received standard milk. The children will be examined at baseline, the pH in saliva will be taken, samples of saliva, plaque index. Their teeth will be brush and them make the evaluation of dental caries with the International Caries Detection and Assessment System (ICDAS). It will start the supply of milk with probiotics and without probiotics. At three, six, nine and twelve months milk consumption controls will be made to children. Controls consist of taking the pH before the milk consumption. Pass an hour it will take again to the children salivary pH; saliva samples, the plaque index. The teeth will be brush and them make the evaluation of dental caries with the International Caries Detection and Assessment System (ICDAS). The milk supplemented with probiotic contain two probiotic strains (Lactobacillus rhamnosus 5x106 UFC/g and Bifidobacterium Longum 3x106 UFC/g) "Registered Trademark". The milk (test and placebo), identical in taste and appearance, will be supplied in packages separated by the colors "White" or "Blue", The chefs prepare 200 grams of milk to the children every day for five days a week, for twelve months and are served at breakfast. It is made daily children attendance record and the consumption of milk. Parents will be instructed about the report to the staff of the project's adverse effects on the children immediately happen.

Sponsors

Universidad del Valle
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
3 Years to 4 Years
Healthy volunteers
Yes

Inclusion criteria

Healthy children from a general health perspective, with or without cavitated carious lesions at during baseline and tracing three, six, nine and twelve months with ages of 3 years to 4 years, both genders, of the Colombian Institute for family welfare (ICBF) belonging at low socio-economic stratum in the city of Cali, Colombia.

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 and children who are under permanent antibiotic treatment

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026