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

Study Overview
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Brief Summary
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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.

Detailed Description
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Dental caries is a disease caused by a shift in pH balance, resulting in the formation of a biofilm composed mainly of cariogenic microflora. The interaction between this microflora and host factors conditions the deceleration or acceleration of the disease. Some biotechnology tools have been tried based on all this research, including probiotics, intended for a selective control of the etiological agents of caries and the maintenance of oral homeostasis. Methodology: In this study, preschool children belonging to public preschool in Villavicencio and Pasto, Colombia will be invited to participate. After obtaining parent´s informed consent, the children will start commercial milk (nanPro3 Nestlé) intake without probiotic for 3 months. One week after, they will start commercial milk with probiotic during others 3 months. Clinical and microbiological testing of saliva at baseline, 3 m, and 6m will be performed. Differences in salivary pH (before and after a sugar solution), remineralization and demineralization in early Stage Decay and Established decay tooth (according to ICDAS) and quantification of Streptococci of the mutans group. Expected results: Statistically significant decrease in pH drop, demineralization in decay tooth and quantification of Streptococci of the mutans group.

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

Conditions
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Caries, Dental

Intervention / Treatment
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* Dietary Supplement: Commercial Dairy Cow Milk
* Dietary Supplement: Commercial Cow Milk with Probiotic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pre-school children from age 3 to 5. Healthy children from a general health perspective, with early stage decay and established decay 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. Children who don't like milk. Children whit severe decay

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Commercial Cow Milk with Probiotic<br>Probiotic enriched cow milk: 200 ml of commercial nutritive milk fortified with probiotic Lactobacillus rhamnosus and Bifidobacterium longum once a day. | Dietary Supplement: Commercial Cow Milk with Probiotic<br>* 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.<br>|
| Placebo Comparator: Commercial Dairy Cow Milk<br>200 ml of commercial nutritive milk without probiotic, once a day, | Dietary Supplement: Commercial Dairy Cow Milk<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in remineralization of tooth decay | DIAGNOdent peak reading in three moments,at the beginning and at the end of the milk without probiotic (after 3 months), and at the end of the milk with probiotic (after 3 months) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of pH of saliva before and after a rinse with sugar. | Saliva pH test in three moments,at the beginning and at the end of the milk without probiotic (after 3 months), and at the end of the milk with probiotic (after 3 months). | 3 months | 
| Change of Dental Plaque Index | Silness-Löe plaque index n three moments,at the beginning and at the end of the milk without probiotic (after 3 months), and at the end of the milk with probiotic (after 3 months). | 3 months | 
| Change of concentration of group mutans streptococci in saliva | Co(after 3 months).lony Forming Units (CFUs) determination in three moments,at the beginning and at the end of the milk without probiotic (after 3 months), and at the end of the milk with probiotic | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotic, Child, Care, dental