Caries ReductionProbioticsNCT01648075
Effect of the Consumption of Probiotics in the Reduction of Incidence of Carious Lesions in Preschool Children
A study testing Experimental: Probiotic enriched milk in people with Caries Reduction and Caries Prevention, run by University of Chile at 1 site in Chile.
Trial summary
Probiotics are microorganisms that when administered in adequate amounts can confer health benefits. In vitro and clinical studies support the idea that lactobacilli have protective effects on oral health. Read more about this study
- Who is it for?
- Ages 2 to 3 years
- Conditions the study is for
- Caries Reduction, Caries Prevention
- What is being tested?
- Experimental: Probiotic enriched milk
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 261 participants
- Where
- 1 siteChile
- Study dates
- Jul 2012to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Healthy children from a general health perspective, with or without cavitated carious lesions at baseline.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Consumption of Probiotics Lactobacilli Enriched Milk in the Reduction of Incidence of Carious Lesions in Preschool Children
Probiotics are microorganisms that when administered in adequate amounts can confer health benefits. In vitro and clinical studies support the idea that lactobacilli have protective effects on oral health. A recent study in which preschoolers consumed milk drinks enriched with Lactobacillus rhamnosus, reported a reduction in caries, as well as additional benefits to children.
The aim of this study is to evaluate the effect of daily consumption of milk beverages enriched with Lactobacillus rhamnosus on the incidence of caries in preschool Chilean children.
Read the detailed description
In this randomized controlled trial, preschool children belonging to Integra Foundation will be invited to participate. After obtaining parent´s informed consent, clinical and microbiological testing of saliva at baseline, 6 m, 12m and 18m will be performed. Differences in prevalence and incidence of caries, dmft and microbial diversity between groups will be assessed.
- Conditions
- Caries Reduction, Caries Prevention
- Being tested
- Experimental: Probiotic enriched milk
- Keywords
- caries, probiotics, lactobacilli
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Probiotic enriched milkDietary supplement
Also called probiotic: Lactobacillus rhamnosus
Milk will be enriched with lactobacillus rhamnosus for the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Probiotic enriched milk | Experimental | 150 ml of skimmed milk enriched with probiotic (Lactobacillus rhamnosus LRH08) once a day Receives: Dietary Supplement: Experimental: Probiotic enriched milk |
| Skimmed Milk | Placebo comparator | 150 ml of skimmed milk once a day Receives: Dietary Supplement: Experimental: Probiotic enriched milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of caries incidence in 1 unit of DMF-T (decayed, missing and filled teeth) from baseline up to the 18th month
Preschool children that in regular basis consume enriched milk with probiotics will present less caries incidence than those that consume milk without probiotics, measured by differences in dmft index between baseline, 6 months, 12 months and 18 months dental exams.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Caries ReductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gonzalo Rodriguez, DDS, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01648075
- Sponsor's protocol ID
- Universidad de Chile
- Acronym
- Probiotics
- Status last verified
- Jan 2014
- First submitted
- 9 Jul 2012
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Ibacache RC, Faleiros S, Diaz-Dosque M, Ruiz B, Contador R, Moreno B, Godoy EF, Martinez GR. Effect of probiotic supplementation on the progression of non-cavitated carious lesions in children: A 12-month randomized controlled trial. Eur J Oral Sci. 2026 Apr;134(2):e70061. doi: 10.1111/eos.70061. Epub 2025 Dec 15.
PubMed 41398922Rodriguez G, Ruiz B, Faleiros S, Vistoso A, Marro ML, Sanchez J, Urzua I, Cabello R. Probiotic Compared with Standard Milk for High-caries Children: A Cluster Randomized Trial. J Dent Res. 2016 Apr;95(4):402-7. doi: 10.1177/0022034515623935. Epub 2016 Jan 8.
PubMed 26747421
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Consumption of Probiotics Lactobacilli Enriched Milk in the Reduction of Incidence of Carious Lesions in Preschool Children
- ClinicalTrials.gov ID
- NCT01648075
- Acronym / sponsor ID
- Probiotics / Universidad de Chile
- Conditions
- Caries Reduction, Caries Prevention
- Keywords
- caries, probiotics, lactobacilli
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 24 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Probiotics are microorganisms that when administered in adequate amounts can confer health benefits. In vitro and clinical studies support the idea that lactobacilli have protective effects on oral health. A recent study in which preschoolers consumed milk drinks enriched with Lactobacillus rhamnosus, reported a reduction in caries, as well as additional benefits to children.
The aim of this study is to evaluate the effect of daily consumption of milk beverages enriched with Lactobacillus rhamnosus on the incidence of caries in preschool Chilean children.
Detailed description
In this randomized controlled trial, preschool children belonging to Integra Foundation will be invited to participate. After obtaining parent´s informed consent, clinical and microbiological testing of saliva at baseline, 6 m, 12m and 18m will be performed. Differences in prevalence and incidence of caries, dmft and microbial diversity between groups will be assessed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Probiotic enriched milk | Experimental | Dietary Supplement: Experimental: Probiotic enriched milk150 ml of skimmed milk enriched with probiotic (Lactobacillus rhamnosus LRH08) once a day |
| Skimmed Milk | Placebo comparator | Dietary Supplement: Experimental: Probiotic enriched milk150 ml of skimmed milk once a day |
Who may qualify
- Ages
- 2 to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy children from a general health perspective, with or without cavitated carious lesions at baseline.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: Probiotic enriched milkAlso: probiotic: Lactobacillus rhamnosusMilk will be enriched with lactobacillus rhamnosus for the experimental group. | Dietary supplement | Experimental: Probiotic enriched milk, Skimmed Milk |
Primary outcome
Reduction of caries incidence in 1 unit of DMF-T (decayed, missing and filled teeth) from baseline up to the 18th month
Time frame: 18 months
Preschool children that in regular basis consume enriched milk with probiotics will present less caries incidence than those that consume milk without probiotics, measured by differences in dmft index between baseline, 6 months, 12 months and 18 months dental exams.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2014.
- Derived from this study: PubMed 41398922Ibacache RC, Faleiros S, Diaz-Dosque M, Ruiz B, Contador R, Moreno B, Godoy EF, Martinez GR. Effect of probiotic supplementation on the progression of non-cavitated carious lesions in children: A 12-month randomized controlled trial. Eur J Oral Sci. 2026 Apr;134(2):e70061. doi: 10.1111/eos.70061. Epub 2025 Dec 15.
- Derived from this study: PubMed 26747421Rodriguez G, Ruiz B, Faleiros S, Vistoso A, Marro ML, Sanchez J, Urzua I, Cabello R. Probiotic Compared with Standard Milk for High-caries Children: A Cluster Randomized Trial. J Dent Res. 2016 Apr;95(4):402-7. doi: 10.1177/0022034515623935. Epub 2016 Jan 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Probiotic enriched milk in people with Caries Reduction and Caries Prevention, run by University of Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of caries incidence in 1 unit of DMF-T (decayed, missing and filled teeth) from baseline up to the 18th month (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01648075, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2014.