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

Not Applicable

Completed

• Conditions: Caries, Dental
• Interventions: Dietary Supplement: Commercial Cow Milk with Probiotic; Dietary Supplement: Commercial Dairy Cow Milk

• Registration Number: NCT03078179
• Lead Sponsor: Cooperative University of Colombia

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2017-03-03
• Study First Submitted QC: 2017-03-07
• Study First Posted: 2017-03-13
• Study Start: 2017-06-05
• Primary Completion: 2017-08-20
• Study Completion: 2018-05-05
• Status Verified: 2018-06
• Last Update Submitted: 2018-07-19
• Last Update Posted: 2018-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Commercial Cow Milk with Probiotic	Commercial Cow Milk with Probiotic	Probiotic enriched cow milk: 200 ml of commercial nutritive milk fortified with probiotic Lactobacillus rhamnosus and Bifidobacterium longum once a day.
Commercial Dairy Cow Milk	Commercial Dairy Cow Milk	200 ml of commercial nutritive milk without probiotic, once a day,

Primary Outcome Measures

Name	Time	Method
Change in remineralization of tooth decay	3 months	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)

Secondary Outcome Measures

Name	Time	Method
Change of Dental Plaque Index	3 months	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).
Change of pH of saliva before and after a rinse with sugar.	3 months	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).
Change of concentration of group mutans streptococci in saliva	3 months	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

Trial Locations

Locations (3)

Cdi Nidos Nutrir; 🇨🇴 Pasto, Colombia

Hogar Infantil 20 de Julio; 🇨🇴 Villavicencio, Meta, Colombia

Hogar Infantil La Esperanza; 🇨🇴 Villavicencio, Meta, Colombia