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

NCT03078179 | Completed

• 1 other identifier: ID 1532
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

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.

Conditions

Caries, Dental

Keywords

Probiotic; Child; Care, dental

Outcome Measures

Primary Outcomes (1)

• 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)

  3 months

Secondary Outcomes (3)

• Change of pH of saliva before and after a rinse with sugar.

  3 months

• Change of Dental Plaque Index

  3 months

• Change of concentration of group mutans streptococci in saliva

  3 months

Study Arms (2)

Commercial Cow Milk with Probiotic

EXPERIMENTAL

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

Dietary Supplement: Commercial Cow Milk with Probiotic

Commercial Dairy Cow Milk

PLACEBO COMPARATOR

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

Dietary Supplement: Commercial Dairy Cow Milk

Interventions

Commercial Dairy Cow Milk DIETARY_SUPPLEMENT

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.

Commercial Dairy Cow Milk

Commercial Cow Milk with Probiotic DIETARY_SUPPLEMENT

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.

Commercial Cow Milk with Probiotic

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Pre-school children from age 3 to 5.
• Healthy children from a general health perspective, with early stage decay and established decay

You may not qualify if:

• 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

Sponsors & Collaborators

• Cooperative University of Colombia: lead
• Colgate Palmolive: collaborator

Study Sites (3)

Hogar Infantil 20 de Julio

Villavicencio, Meta Department, 500001, Colombia

Location

Hogar Infantil La Esperanza

Villavicencio, Meta Department, 500001, Colombia

Location

Cdi Nidos Nutrir

Pasto, Colombia

Location

Related Publications (4)

• 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.

  PMID: 12446187 BACKGROUND

• 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.

  PMID: 21454978 BACKGROUND

• 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.

  PMID: 19479452 BACKGROUND

• 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.

  PMID: 11799281 RESULT

MeSH Terms

Conditions

Dental Caries

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• María del Pilar Angarita, PhD

  Cooperative University of Colombia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2017
• First Posted: March 13, 2017
• Study Start: June 5, 2017
• Primary Completion: August 20, 2017
• Study Completion: May 5, 2018
• Last Updated: July 23, 2018

Record last verified: 2018-06

Locations

CO (3)