CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 enrolled
Drug / intervention
Commercial Dairy Cow Milk +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03078179
NCT03078179N/ACompleted

Effect of Lactobacillus Rhamnosus GG and Bifidobacterium Longum in Children Aged 3 to 5 Years of Villavicencio and Pasto

Cooperative University of Colombia·interventional·Posted Mar 13, 2017·Updated Jul 23, 2018

In Brief

A clinical study evaluating Commercial Dairy Cow Milk and Commercial Cow Milk with Probiotic for Caries, Dental. Completed, enrolled 100 participants across 3 sites.

Detailed Summary

The objective of this pilot study is to determine if the presence of bacteria with probiotic characteristics (Lactobacillus rhamnosus GG and Bifidobacterium longum) in a commercial milk, control some measures that indicate cariogenic processes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCaries, Dental
CountriesColombia
CollaboratorsColgate Palmolive

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMar 13, 2017
Enrollment StartJun 5, 2017
Primary CompletionAug 20, 2017
Study CompletionMay 5, 2018
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 9.3 years ago

Interventions

Commercial Dairy Cow Milkdietary

After obtaining parent´s informed consent and the baseline examination, from 3 to 5 years old, will start commercial dairy cow milk intake without probiotic (placebo) for 3 months. Clinical and microbiological testing of saliva at baseline and at the end will be performed. Differences in salivary pH (before and after a sugar solution), remineralization and demineralization in early Stage Decay and quantification of Streptococci of the mutans group.

Commercial Cow Milk with Probioticdietary

The children will initiate the milk intake with probiotic one week after having ingested the milk without probiotics. They will drink the milk with probiotic for 3 months. Clinical and microbiological testing of saliva will be performed. Clinical and microbiological testing of saliva at baseline and at the end will be performed. Differences in salivary pH (before and after a sugar solution), remineralization and demineralization in early Stage Decay and quantification of Streptococci of the mutans group.