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

Cooperative University of Colombia

Status: Completed

Conditions: Caries, Dental

Treatments: Dietary Supplement: Commercial Dairy Cow Milk; Dietary Supplement: Commercial Cow Milk with Probiotic

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03078179

ID 1532

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 3 to 5 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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100 participants in 2 patient groups, including a placebo group

Commercial Cow Milk with Probiotic

Experimental group

Description:

Probiotic enriched cow milk: 200 ml of commercial nutritive milk fortified with probiotic Lactobacillus rhamnosus and Bifidobacterium longum once a day.

Treatment:

Dietary Supplement: Commercial Cow Milk with Probiotic

Commercial Dairy Cow Milk

Placebo Comparator group

Description:

200 ml of commercial nutritive milk without probiotic, once a day,

Treatment:

Dietary Supplement: Commercial Dairy Cow Milk