ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03078179
Recruitment Status : Recruiting
First Posted : March 13, 2017
Last Update Posted : August 7, 2017
Sponsor:
Collaborator:
Colgate Palmolive
Information provided by (Responsible Party):
Cooperative University of Colombia

Brief Summary:
The objective of this study is to determine if the presence of bacterias with probiotic characteristics (Lactobacillus rhamnosus GG and Bifidobacterium longum) in a commercial milk, control some measures that indicate cariogenic processes.

Condition or disease Intervention/treatment Phase
Caries, Dental Dietary Supplement: Commercial Cow Milk with Probiotic Dietary Supplement: Commercial Dairy Cow Milk Not Applicable

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 during 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 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Repeated measures design
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Lactobacillus Rhamnosus GG and Bifidobacterium Longum in Children Aged 3 to 5 Years of Villavicencio and Pasto
Actual Study Start Date : June 5, 2017
Estimated Primary Completion Date : August 28, 2017
Estimated Study Completion Date : December 10, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Commercial Cow Milk with Probiotic

Probiotic enriched cow milk:

150 ml of commercial milk fortified with probiotic Lactobacillus rhamnosus and Bifidobacterium longum once a day

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 during 3 months. Clinical and microbiological testing of saliva will be performed. Differences in salivary pH (before and after a sugar solution), remineralization and desmineralization in early Stage Decay and Established decay tooth (according ICDAS) and quantification of Streptococci of the mutans group.

Placebo Comparator: Commercial Dairy Cow Milk
150 ml of commercial nutrition milk without probiotic, once a day
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) during 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 desmineralization in early Stage Decay and Established decay tooth (according ICDAS) and quantification of Streptococci of the mutans group.




Primary Outcome Measures :
  1. Change in remineralization of tooth decay [ Time Frame: 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 :
  1. Change of pH of saliva before and after a rinse with sugar. [ Time Frame: 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).

  2. Change of Dental Plaque Index [ Time Frame: 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).

  3. Change of concentration of group mutans streptococci in saliva [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   3 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03078179


Contacts
Contact: María del Pilar Angarita, PhD (+061)3008983524 maria.angaritad@campusucc.edu.co

Locations
Colombia
Hogar Infantil 20 de Julio Recruiting
Villavicencio, Meta, Colombia, 500001
Contact: Maira Alexandra Prieto, Director         
Hogar Infantil La Esperanza Recruiting
Villavicencio, Meta, Colombia, 500001
Contact: Olga Rojas, Director         
Sponsors and Collaborators
Cooperative University of Colombia
Colgate Palmolive
Investigators
Principal Investigator: María del Pilar Angarita, PhD Cooperative University of Colombia

Publications of Results:
Other Publications:
Responsible Party: Cooperative University of Colombia
ClinicalTrials.gov Identifier: NCT03078179     History of Changes
Other Study ID Numbers: ID 1532
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: August 7, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by Cooperative University of Colombia:
Probiotic
Child
Care, dental

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Sulfalene
Anti-Infective Agents
Anti-Infective Agents, Urinary
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents