Dietary SupplementNCT03998306
Probiotics in Children With Early Childhood Caries
A study testing Experimental: Probiotics in people with Dietary Supplement, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
The purpose of this study is to determine if probiotic lozenges taken once a day before bedtime for twelve weeks can decrease the numbers of Streptococcus mutans Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Supplement
- What is being tested?
- Experimental: Probiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 19 Jul 2019to Jan 2020
- 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 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- generally healthy children aged 3-6;
- recognized caries of early childhood, dmf> 1,
- lack of active caries and inflammation of the mouth
- CFU> 105 / ml Streptococcus mutans
- a minimum of one-month period from: the last antibiotic therapy, probiotic use, professional fluoride prophylaxis or supervised tooth brushing with fluoride preparations, the use of fluoride toothpaste, not using xylitol, written consent of parents / legal guardians for participation in research.
Who cannot join
- chronic diseases and chronically taken medicines in the past,
- planned change of residence during the year,
- age below 3 and above 6 years,
- healthy teeth, dmf = 0,
- CFU <105 / ml Streptococcus mutans
- Patient during antibiotic therapy, probiotic use, professional fluoride prophylaxis or supervised tooth brushing with fluoride preparations
Show all 9Show fewer
- no toothpaste with fluoride
- using xylitol
- lack of written consent of parents / legal guardians for participation in research.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Dorota Olczak-Kowalczyk
Warsaw, Warsaw, 18 Miodowa Saint, 00-246
Dorota Olczak-Kowalczyk, Ass.Prof., +48 22 502 20 31, pedodoncja@wum.edu.pl
Anna Turska-Szybka, Phd, MD
About this study
Official title: Influence of the Probiotic Streptococcus Salivarius K12 on Dental Health in Children With Early Childhood Caries
The purpose of this study is to determine if probiotic lozenges taken once a day before bedtime for twelve weeks can decrease the numbers of Streptococcus mutans
Read the detailed description
Streptococcus salivarius is one of the commensal bacteria of the mouth and the main component of biofilm. Research indicates that some microorganisms present in plaque, which until recently were considered not to cause caries, including Streptococcus salivarius, present in the supragingival microbiome, can also cause tooth decay.
- Conditions
- Dietary Supplement
- Being tested
- Experimental: Probiotics, No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: ProbioticsDietary supplement
the participants will receive probiotic lozenge before falling asleep for 12 weeks.
the participants will receive dietetic and hygienic instructions
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Experimental | A half of the participants will be randomly allocated to the probiotics group. They will receive probiotic lozenge before falling asleep for12 weeks. They will receive hygienic and dietetic instructions. examination will be conducted before study and after 12 weeks. Receives: Dietary Supplement: Experimental: Probiotics |
| CONTROL | Sham comparator | no intervention Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changing the amount of carcinogenic bacteria Streptococcus mutans in intervention group based on bacterial test counting number of Colony Forming Units
During control test saliva will be applied to the medium for identification and detailed quantification of Streptococcus mutans bacteria. After the incubation, the number of bacteria will be expressed - taking into account the degree of saliva dilution - as the number of colony-forming unit (CFU) in 1 ml of saliva. colony forming unit CFU in intervention and control groups. Bacterial tests will be used to assess this outcome measure. We expect decrement of amount of cariogenic bacteria in intervention group
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start19 Jul 2019
- Primary completionDec 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary SupplementStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03998306
- Sponsor's protocol ID
- KB/202/2017
- Status last verified
- Apr 2019
- First submitted
- 15 Apr 2019
- Last updated
- 31 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Probiotic Streptococcus Salivarius K12 on Dental Health in Children With Early Childhood Caries
- ClinicalTrials.gov ID
- NCT03998306
- Acronym / sponsor ID
- KB/202/2017
- Conditions
- Dietary Supplement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 19 Jul 2019 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 26 Jun 2019 (actual)
- 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.
The purpose of this study is to determine if probiotic lozenges taken once a day before bedtime for twelve weeks can decrease the numbers of Streptococcus mutans
Detailed description
Streptococcus salivarius is one of the commensal bacteria of the mouth and the main component of biofilm. Research indicates that some microorganisms present in plaque, which until recently were considered not to cause caries, including Streptococcus salivarius, present in the supragingival microbiome, can also cause tooth decay.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics | Experimental | Dietary Supplement: Experimental: ProbioticsA half of the participants will be randomly allocated to the probiotics group. They will receive probiotic lozenge before falling asleep for12 weeks. They will receive hygienic and dietetic instructions. examination will be conducted before study and after 12 weeks. |
| CONTROL | Sham comparator | Other: No interventionno intervention |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- generally healthy children aged 3-6;
- recognized caries of early childhood, dmf> 1,
- lack of active caries and inflammation of the mouth
- CFU> 105 / ml Streptococcus mutans
- a minimum of one-month period from: the last antibiotic therapy, probiotic use, professional fluoride prophylaxis or supervised tooth brushing with fluoride preparations, the use of fluoride toothpaste, not using xylitol, written consent of parents / legal guardians for participation in research.
Key exclusion criteria (9 listed)
- chronic diseases and chronically taken medicines in the past,
- planned change of residence during the year,
- age below 3 and above 6 years,
- healthy teeth, dmf = 0,
- CFU <105 / ml Streptococcus mutans
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: Probioticsthe participants will receive probiotic lozenge before falling asleep for 12 weeks. the participants will receive dietetic and hygienic instructions | Dietary supplement | Probiotics |
| No interventionNo intervention | Other | CONTROL |
Primary outcome
Changing the amount of carcinogenic bacteria Streptococcus mutans in intervention group based on bacterial test counting number of Colony Forming Units
Time frame: 12 weeks
During control test saliva will be applied to the medium for identification and detailed quantification of Streptococcus mutans bacteria. After the incubation, the number of bacteria will be expressed - taking into account the degree of saliva dilution - as the number of colony-forming unit (CFU) in 1 ml of saliva. colony forming unit CFU in intervention and control groups. Bacterial tests will be used to assess this outcome measure. We expect decrement of amount of cariogenic bacteria in intervention group
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2019.
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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.
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: Probiotics in people with Dietary Supplement, run by Medical University of Warsaw at 1 site in Poland.
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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 31 Oct 2019. 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 Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changing the amount of carcinogenic bacteria Streptococcus mutans in intervention group based on bacterial test counting number of Colony Forming Units (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Oct 2019.