Condition category
Not Applicable
Date applied
30/12/2017
Date assigned
20/03/2018
Last edited
13/02/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Probiotics are live bacteria and yeasts promoted as having various health benefits. Fermented foods contain several probiotic bacteria that provide benefits especially on a digestive level. Previous research has analyzed the effect of probiotics in the mouth and have shown that certain probiotic microorganisms could reduce the saliva levels of the bacteria Mutans streptococci and Lactobacilli sp., which play an important role in the development of tooth cavities, but this effect has not been widely assessed for two probiotics (Lactobacillus casei and Lactobacillus acidophilus) available in some commercial yogurt brands in Colombia (‘Original’ Yogurt, manufactured by Alpina S.A.). Therefore, the aim of this study is to assess the effects of Lactobacillus casei and Lactobacillus acidophilus available in yogurt on the saliva levels of Mutans streptococci and Lactobacilli sp. in a population of Colombian children aged 6-12.

Who can participate?
Healthy children aged 6-12

What does the study involve?
Participants are randomly allocated into two groups. Those in group A drink ‘Original’ yogurt containing probiotics (Lactobacillus casei and Lactobacillus acidophilus) and group B drink ‘Yogo-Yogo’ ordinary yogurt without probiotics. Every child receives 150 g of the assigned yogurt after their lunch for five week days during three months. The children are encouraged to maintain their normal oral hygiene habits and continue to brush their teeth daily.

What are the possible benefits and risks of participating?
The children who take part in this study are given the benefit of drinking a beverage with many nutrients which either had probiotics or did not. There are no risks because the yogurt used is available in all supermarkets in the city of Bucaramanga (Colombia).

Where is the study run from?
The charity restaurant “Maria Reina de las Misiones” (Colombia)

When is study starting and how long is it expected to run for?
November 2013 to November 2017

Who is funding the study?
Universidad Santo Tomas (Colombia)

Who is the main contact?
Prof. Martha J. Rodriguez
marthajuro@gmail.com

Trial website

Contact information

Type

Public

Primary contact

Mr Jose Pieruccini

ORCID ID

http://orcid.org/0000-0002-5098-5130

Contact details

Calle 147 No. 25 - 30 Palmas del Campo Torre C Apto. 402
Floridablanca
681004
Colombia
+57 (0)3017850598
josepieruccini@ustabuca.edu.co

Type

Scientific

Additional contact

Prof Martha Rodríguez

ORCID ID

http://orcid.org/0000-0001-7339-7836

Contact details

Torres del Club
Carrera 21 # 36-83
Floridablanca
681004
Colombia
+57 (0)315 8169925
marthajuro@ustabuca.edu.co

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

GIFODONTP42014

Study information

Scientific title

Effects of yogurt containing probiotics on salivary Streptococcus mutans and Lactobacillus sp. counts in Colombian children aged from 6 to 12 years: a randomised controlled clinical trial

Acronym

Study hypothesis

Lactobacillus casei and Lactobacillus acidophilus probiotics which are available in a yogurt called ‘Original’ distributed by Alpina S.A. reduce salivary Streptococcus mutans and Lactobacillus sp. counts in six to twelve year old Colombian children.

Ethics approval

The Research Ethics Committee of the Dentistry School at the Universidad Santo Tomas in Bucaramanga (Colombia), 22/05/2014

Study design

Single-centre single-blind randomised placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Healthy children not being under antibiotic therapy the two previous months to the start of the intervention

Intervention

The children were randomised by block randomisation into group A (intervention arm: ‘Original’ probiotics yogurt containing Lactobacillus casei and Lactobacillus acidophilus) or group B (placebo control arm: ‘Yogo-Yogo’ ordinary yogurt without probiotics). Every participant received 150g of the assigned intake after their lunch during weekdays only, for a three month period.

Microbiological examinations were performed at baseline and at the end of the intervention period. Samples of stimulated whole saliva were collected directly into sterile sample bottles. In the laboratory, samples were vortexed for 30 seconds and serially diluted from 10-1 to 10-3. Two inoculums for each dilution were plated on selective agar, Mitis Salivarius-Bacitracin agar for Streptococcus mutans and Rogosa agar for Lactobacillus sp. The agar plates were coded and anaerobically incubated at 37°. The number of CFU were identified based on their morphology, size, and color with the help of a digital colony counter 24 hours after incubation for Rogosa agar plates and 48 hours for Mitis Salivarius-Bacitracin agar plates. Biochemical identification tests were also used for identification of microorganisms. CFU of individual species were estimated by a single trained investigator.

Intervention type

Supplement

Phase

Drug names

Primary outcome measure

Streptococcus mutans and Lactobacillus sp. Colony Forming Units (CFU) counts; microbiological examinations performed at baseline and at the end of the intervention period

Secondary outcome measures

Salivary pH measured using a calibrated digital pH-meter and buffering capacity at baseline and at the end of the intervention period

Overall trial start date

01/11/2013

Overall trial end date

24/11/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Healthy children
2. Both genders
3. Age 6-12 years old
4. Lactose tolerant

Participant type

Healthy volunteer

Age group

Child

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. Dry mouth or xerostomy
2. Morbid obesity
3. Antibiotic therapy

Recruitment start date

16/07/2017

Recruitment end date

16/08/2017

Locations

Countries of recruitment

Colombia

Trial participating centre

Comedor Infantil Maria Reina de las Misiones (a charity restaurant for children)
Bucaramanga
681002
Colombia

Sponsor information

Organisation

Universidad Santo Tomás

Sponsor details

Carrera 27 No. 180 - 395
Autopista Floridablanca
Floridablanca
681004
Colombia
6800801
decodo@ustabuca.edu.co

Sponsor type

University/education

Website

http://www.ustabuca.edu.co/

Funders

Funder type

University/education

Funder name

Universidad Santo Tomás

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Martha J. Rodriguez (marthajuro@gmail.com or marthajuro@ustabuca.edu.co).

Intention to publish date

02/02/2018

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes