NCT03078179

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Cooperative University of Colombia · Academic / Other
• Sex: All
• Age: 3 Years – 5 Years
• Healthy volunteers: Accepted

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.

Conditions

• Caries, Dental

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Commercial Dairy Cow Milk	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.
DIETARY_SUPPLEMENT	Commercial Cow Milk with Probiotic	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.

Timeline

• Start date: 2017-06-05
• Primary completion: 2017-08-20
• Completion: 2018-05-05
• First posted: 2017-03-13
• Last updated: 2018-07-23

Locations

3 sites across 1 country: Colombia