Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001363471
Ethics application status
Approved
Date submitted
5/03/2015
Date registered
30/09/2016
Date last updated
22/09/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of a food enriched with probiotics based Lactobacillus rhamnosus GG on the count of Streptococcus mutans and Lactobacillus sp and the presence of incipient caries in children 3 to 4 years in Cali, Colombia
Scientific title
Effects of a food enriched with probiotics based Lactobacillus rhamnosus GG on the count of Streptococcus mutans and Lactobacillus sp and the presence of incipient caries in children 3 to 4 years in Cali, Colombia
Secondary ID [1] 286287 0
none
Universal Trial Number (UTN)
Trial acronym
none
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dental caries 294369 0
Condition category
Condition code
Infection 294683 294683 0 0
Studies of infection and infectious agents
Oral and Gastrointestinal 300072 300072 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A total number of 360 children were cluster randomized assigned to two groups: children in the intervention group were served milk supplemented with probiotic and the control group received standard milk.

The children will be examined at baseline, the pH in saliva will be taken, samples of saliva, plaque index. Their teeth will be brush and them make the evaluation of dental caries with the International Caries Detection and Assessment System (ICDAS).

It will start the supply of milk with probiotics and without probiotics. At three, six, nine and twelve months milk consumption controls will be made to children.

Controls consist of taking the pH before the milk consumption. Pass an hour it will take again to the children salivary pH; saliva samples, the plaque index. The teeth will be brush and them make the evaluation of dental caries with the International Caries Detection and Assessment System (ICDAS).

The milk supplemented with probiotic contain two probiotic strains (Lactobacillus rhamnosus 5x106 UFC/g and Bifidobacterium Longum 3x106 UFC/g) "Registered Trademark". The milk (test and placebo), identical in taste and appearance, will be supplied in packages separated by the colors "White" or "Blue",

The chefs prepare 200 grams of milk to the children every day for five days a week, for twelve months and are served at breakfast. It is made daily children attendance record and the consumption of milk.

Parents will be instructed about the report to the staff of the project's adverse effects on the children immediately happen.
Intervention code [1] 291314 0
Prevention
Comparator / control treatment
200 grams of milk without probiotic content will be provided daily for five days a week over a period of twelve months
Control group
Active

Outcomes
Primary outcome [1] 294437 0
Count of colony-forming units' (CFU) of Streptococcus mutans and Lactobacillus sp.

Participants will be requested to void saliva into a wide-mouthed disposable tube after their breakfast. Saliva (0,1 mL) will be diluted with 0,9 mL of sterile saline solution and tenfold serial dilutions of saliva will be made up to 103, before plating.

Mitis Salivarius Agar (MSA) supplemented with potassium tellurite and bacitracine will be used as culture media for isolation of total salivary Streptococci and Rogosa agar will be prepared for the growth of Lactobacilli. Appropriate amounts of semisolid media will be poured onto petri plates in a laminar air flow unit and allowed to solidify at room temperature.

To each plate 100 microlitres of the diluted sample will be spread evenly and the plates will be sealed, placed in an anaerobic jar with Anaero Gas Pack system, and incubated at 37 degrees Celsius for 48 hours. Bacterial colonies will be observed under a dissecting microscope and deduced on the basis of colony morphology, shape and color; and in case of doubt confirmation for Streptococci and Lactobacilli will be done by gram staining or catalase tests, respectively. The number of CFU will be multiplied by the number of times the original mL of sample will be diluted (the dilution factor of the plate counted) and expressed as the number of colony forming units per milliliter (CFU/mL) of saliva.
Timepoint [1] 294437 0
12 months
Secondary outcome [1] 313312 0
1. Dental caries lesions: Clinical dental examinations will be performed at baseline and tracing at three, six, nine and twelve months of the study. One dentist, using an artificial light, a mouth mirror, will examine all of the children at the nursery schools. ICDAS (International Caries Detection and Assessment System) criteria were used for the visual and tactile detection of dental caries lesions and for describing the severity of lesions. The essential elements of the ICDAS caries detection codes, are the visual criteria for the full series of six caries codes, using from the histologically more extensive distinct visual change which is visible wet or dry from code 2 through steps to the most severe stage, the extensive distinct cavity with visible dentine until code 6, during baseline and tracing three, six, nine and twelve months.
Timepoint [1] 313312 0
baseline, 3, 6, 9 and 12 months.
Secondary outcome [2] 327967 0
2. Presence of bacterial plaque: Using a mouth mirror, gauze, and a dental probe under a focusable flashlight was recorded the presence or absence of clinically visible plaque, during baseline and tracing three, six, nine and twelve months
Timepoint [2] 327967 0
Baseline, 3, 6 , 9 and 12 months
Secondary outcome [3] 327968 0
3. Salivary pH: For pH saliva, the testing lead tape into mouth saliva for three seconds, is removed and compare to color chart of pH testing tape it to get a value of pH, digital pH meter analyzed the collected saliva, during baseline and tracing at three, six, nine and twelve months
Timepoint [3] 327968 0
Baseline 3, 6, 9 and 12 months
Secondary outcome [4] 327969 0
4.Salivary buffer capacity: Measured salivary pH values both before and after addition of acid (HCl) to assess salivary buffer capacity, It was obtained by mixing 1 ml of saliva with 3 ml HCl in a tube and measuring the solution pH with digital pH meter after 20 minutes in vortex mixer, during baseline and tracing at three, six, nine and twelve months
Timepoint [4] 327969 0
baseline 3, 6, 9 and 12 months

Eligibility
Key inclusion criteria
Healthy children from a general health perspective, with or without cavitated carious lesions at during baseline and tracing three, six, nine and twelve months with ages of 3 years to 4 years, both genders, of the Colombian Institute for family welfare (ICBF) belonging at low socio-economic stratum in the city of Cali, Colombia.
Minimum age
3 Years
Maximum age
4 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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 and children who are under permanent antibiotic treatment

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment was done by : sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
Type of sampling: probabilistic cluster sampling. The sampling frame will correspond to three headquarters of the ICBF of the city of Cali, Colombia, that be the primary sampling unit, the random participants selected by each (secondary sampling unit) headquarters for an estimated 360 children. The calculation of the sample was based on the driving a confidence level of 90% and a power of 0.80 (80% power for a good sampling). Sample size: 360 children.

The information will be well-typed in duplicate in rules created for that purpose as the study progresses. These will be validated through the Epidata 3.1 software so as to obtain a fully refined base.

Analysis of the information: initially, it will be described and compared study on the baseline population. The information to be processed using descriptive statistics for each of the variables (measures of central tendency and dispersion and proportions according to the type of variable frequency) using 95% confidence intervals. For the comparison between groups (intervened and control), will be used parametric statistics where variables assume a Normal distribution. Non-parametric tests will be used otherwise. Likewise, an analysis will be held by Protocol. Use the statistical package Stata 13.0 “Marca registrada” assuming a p-value < 0.05 as significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/10/2016
Actual
15/10/2016
Date of last participant enrolment
Anticipated
Actual
14/07/2017
Date of last data collection
Anticipated
Actual
14/07/2017
Sample size
Target
360
Accrual to date
Final
363
Recruitment outside Australia
Country [1] 6709 0
Colombia
State/province [1] 6709 0
Valle

Funding & Sponsors
Funding source category [1] 290850 0
Government body
Name [1] 290850 0
Colciencias
Country [1] 290850 0
Colombia
Primary sponsor type
University
Name
Universidad del Valle
Address
Cll 4B # 36 - 00 Cali, Colombia
Country
Colombia
Secondary sponsor category [1] 289538 0
None
Name [1] 289538 0
Address [1] 289538 0
Country [1] 289538 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292466 0
Universidad del Valle
Ethics committee address [1] 292466 0
Ethics committee country [1] 292466 0
Colombia
Date submitted for ethics approval [1] 292466 0
Approval date [1] 292466 0
30/05/2014
Ethics approval number [1] 292466 0
111-014

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 55430 0
Prof Judy Villavicencio
Address 55430 0
Universidad del Valle, Sede San Fernando. Calle 4B # 36 - 00 Cali, Colombia.
Country 55430 0
Colombia
Phone 55430 0
+ 57 3155793970
Fax 55430 0
Email 55430 0
[email protected]
Contact person for public queries
Name 55431 0
Judy Villavicencio
Address 55431 0
Universidad del Valle, Sede San Fernando. Calle 4B # 36 - 00 Cali, Colombia.
Country 55431 0
Colombia
Phone 55431 0
+ 57 3155793970
Fax 55431 0
Email 55431 0
[email protected]
Contact person for scientific queries
Name 55432 0
Judy Villavicencio
Address 55432 0
Universidad del Valle, Sede San Fernando. Calle 4B # 36 - 00 Cali, Colombia.
Country 55432 0
Colombia
Phone 55432 0
+ 57 3155793970
Fax 55432 0
Email 55432 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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