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

Primary Purpose

Caries, Dental

Status
Completed
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Commercial Dairy Cow Milk
Commercial Cow Milk with Probiotic
Sponsored by
Cooperative University of Colombia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Caries, Dental focused on measuring Probiotic, Child, Care, dental

Eligibility Criteria

3 Years - 5 Years (Child)All SexesAccepts 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

Sites / Locations

  • Hogar Infantil 20 de Julio
  • Hogar Infantil La Esperanza
  • Cdi Nidos Nutrir

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Commercial Cow Milk with Probiotic

Commercial Dairy Cow Milk

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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).
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).
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

Full Information

First Posted
March 3, 2017
Last Updated
July 19, 2018
Sponsor
Cooperative University of Colombia
Collaborators
Colgate Palmolive
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1. Study Identification

Unique Protocol Identification Number
NCT03078179
Brief Title
Effect of Lactobacillus Rhamnosus GG and Bifidobacterium Longum in Children Aged 3 to 5 Years of Villavicencio and Pasto
Official Title
Effect of Lactobacillus Rhamnosus GG and Bifidobacterium Longum in Children Aged 3 to 5 Years of Villavicencio and Pasto
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
June 5, 2017 (Actual)
Primary Completion Date
August 20, 2017 (Actual)
Study Completion Date
May 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cooperative University of Colombia
Collaborators
Colgate Palmolive

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caries, Dental
Keywords
Probiotic, Child, Care, dental

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Commercial Cow Milk with Probiotic
Arm Type
Experimental
Arm Description
Probiotic enriched cow milk: 200 ml of commercial nutritive milk fortified with probiotic Lactobacillus rhamnosus and Bifidobacterium longum once a day.
Arm Title
Commercial Dairy Cow Milk
Arm Type
Placebo Comparator
Arm Description
200 ml of commercial nutritive milk without probiotic, once a day,
Intervention Type
Dietary Supplement
Intervention Name(s)
Commercial Dairy Cow Milk
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Commercial Cow Milk with Probiotic
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in remineralization of tooth decay
Description
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)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change of pH of saliva before and after a rinse with sugar.
Description
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).
Time Frame
3 months
Title
Change of Dental Plaque Index
Description
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).
Time Frame
3 months
Title
Change of concentration of group mutans streptococci in saliva
Description
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
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
María del Pilar Angarita, PhD
Organizational Affiliation
Cooperative University of Colombia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hogar Infantil 20 de Julio
City
Villavicencio
State/Province
Meta
ZIP/Postal Code
500001
Country
Colombia
Facility Name
Hogar Infantil La Esperanza
City
Villavicencio
State/Province
Meta
ZIP/Postal Code
500001
Country
Colombia
Facility Name
Cdi Nidos Nutrir
City
Pasto
Country
Colombia

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
12446187
Citation
Ahola AJ, Yli-Knuuttila H, Suomalainen T, Poussa T, Ahlstrom A, Meurman JH, Korpela R. Short-term consumption of probiotic-containing cheese and its effect on dental caries risk factors. Arch Oral Biol. 2002 Nov;47(11):799-804. doi: 10.1016/s0003-9969(02)00112-7.
Results Reference
background
PubMed Identifier
21454978
Citation
Aminabadi NA, Erfanparast L, Ebrahimi A, Oskouei SG. Effect of chlorhexidine pretreatment on the stability of salivary lactobacilli probiotic in six- to twelve-year-old children: a randomized controlled trial. Caries Res. 2011;45(2):148-54. doi: 10.1159/000325741. Epub 2011 Mar 31.
Results Reference
background
PubMed Identifier
19479452
Citation
Twetman L, Larsen U, Fiehn NE, Stecksen-Blicks C, Twetman S. Coaggregation between probiotic bacteria and caries-associated strains: an in vitro study. Acta Odontol Scand. 2009;67(5):284-8. doi: 10.1080/00016350902984237.
Results Reference
background
PubMed Identifier
11799281
Citation
Nase L, Hatakka K, Savilahti E, Saxelin M, Ponka A, Poussa T, Korpela R, Meurman JH. Effect of long-term consumption of a probiotic bacterium, Lactobacillus rhamnosus GG, in milk on dental caries and caries risk in children. Caries Res. 2001 Nov-Dec;35(6):412-20. doi: 10.1159/000047484.
Results Reference
result

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

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