Diabetes Mellitus,Type 2NCT04913909
Effects of a Probiotic on Oral Microbiota and Glycemic Control in Type 2 Diabetics; A Randomized Clinical Trial
A study of Diabetes Mellitus,Type 2 and Periodontitis, run by Istanbul University.
Trial summary
The present study evaluated clinically the effects of a probiotic on oral microbiota and glycemic control in T2 diabetic patients with periodontal disease. The study was designed as a prospective randomized, double-blind, placebo- controlled interventional study. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Diabetes Mellitus,Type 2, Periodontitis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 10 Sep 2015to 14 Mar 2018
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- being diagnosed with T2 diabetes with <10% HbA1C for at least 6 months,
- 30-65 years old patients,
- high caries activity patients with Periodontal Disease Index (PDI) scores of 2, 3, 4 and 5,
- provision of written informed consent -
Who cannot join
- patients regularly using probiotics,
- patients on corticosteroid, non-steroid anti-inflammatory, antibiotic or antibacterial mouthwash therapy,
- patients with multi-organ deficiency such as liver or kidney failure,
- patients with Immunodeficiency syndrome or on immunosuppressive therapy,
- patients with heart valve prosthesis or central venous catheter,
- patients undergoing chronic or acute disease therapy such as cancer, arthritis, influenza, flu,
- legal incapability or mental incapacity to give consent.
About this study
Official title: Effects of Probiotic Streptococcus Salivarius Strain M18 on Oral Microbiota and Glycemic Control in Patients With Type 2 Diabetes Mellitus; A Randomized Clinical Trial
The present study evaluated clinically the effects of a probiotic on oral microbiota and glycemic control in T2 diabetic patients with periodontal disease. The study was designed as a prospective randomized, double-blind, placebo- controlled interventional study. At baseline and at the end of the 30 day- probiotic period, all clinical, microbiological, and biochemical measurements were tested. Colony counts of oral microbiota, blood fructosamine levels and CRP were the outcomes of the study.
Read the detailed description
Objectives: To investigate the effects of an oral probiotic use, containing 4 billion colony forming unit (CFU/g) Streptococcus Salivarius M18 strain (Dentoblis™), on the quantities of oral microbiota in saliva and metabolic markers of T2 diabetics such as fructosamine, C-reactive protein (CRP).
Materials and Methods: The trial was designed as a prospective randomized, double-blind, placebo- controlled interventional study. Participants were selected from type 2 diabetics with periodontitis and aged 30-65 years, who presented to the Diabetic Center in Istanbul. Totally 70 patients were randomly assigned to probiotic or placebo groups. At baseline and at the end of the 30 day-probiotic period, colony counts of oral microbiota and biochemical measurements of diabetes were assessed.
- Conditions
- Diabetes Mellitus,Type 2, Periodontitis
- Being tested
- Effects of an oral probiotic or placebo use on oral microbiota and glycemic index in Type 2 diabetic patients
- Keywords
- Probiotics, Diabetes mellitus, Oral microbiota, Periodontitis, Streptococcus salivarius M18
- Medical subject headings
- Diabetes Mellitus, Type 2, Periodontitis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effects of an oral probiotic or placebo use on oral microbiota and glycemic index in Type 2 diabetic patientsDietary supplement
The participants were randomized to the interventional groups, probiotic or placebo, by the diabetes nurse. During the intervention period of 30 nights, the participants were asked to let one Dentoblis™ or placebo lozenge slowly melt in their mouth for one minute before going to bed and after tooth brushing. Dentoblis™, as a test lozenge, contains 4x109 CFU/g S. salivarius M18 strain isolated from a healthy oral microbiota and has been utilized as oral probiotic inhibiting dental caries-causing pathogens.
The placebo is indistinguishable in form, size, color, and taste from the probiotic lozenge, but contains no bacteria. Placebo and probiotic lozenges were equivalent to 810 mg each and containing same amount of xylitol. Both were provided by the manufacturer, Bluestone Pharma GmbH, Baar, Switzerland, in equal white containers boxes, separated by production code. Neither the investigators nor the subjects were aware of the contents of the lozenges except for the research nurse.
| Study group | Role | What they receive |
|---|---|---|
| Dentoblis™ group | Active comparator | In Probiotic group; Dentoblis™, as a test lozenge, contains 4 billion CFU/g S. salivarius M18 strain probiotic isolated from a healthy oral microbiota, has been utilized one lozenge a day for 30 days. Receives: Dietary Supplement: Effects of an oral probiotic or placebo use on oral microbiota and glycemic index in Type 2 diabetic patients |
| Placebo group | Placebo comparator | The placebo was indistinguishable in form, size, color, smell and taste from the probiotic lozenge, but contained no bacteria and utilized one lozenge a day for 30 days . Placebo and probiotic lozenges were equivalent to 810 mg each and containing same amount of xylitol. Both were provided by the manufacturer, Bluestone Pharma GmbH, Baar, Switzerland, in equal white containers boxes, separated by production code. Receives: Dietary Supplement: Effects of an oral probiotic or placebo use on oral microbiota and glycemic index in Type 2 diabetic patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Oral Microbiota colony counts at baseline and after intervention
Colony counts of periodontal pathogens, S.mutans and candidas were determined 30 day after the use of the Probiotic in CFU/g
Measured: 30 days
Change in blood fructosamine levels in Type 2 diabetic patients an Oral probiotic use
Clinical marker of Type 2 diabetics such as CRP and fructosamine were determined 30 day after the use of the Probiotic
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start10 Sep 2015
- Primary completion18 May 2017
- Study completion14 Mar 2018
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 Diabetes Mellitus,Type 2Studies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The trial was a prospective randomized, double-blind, placebo-controlled intervention study. All patients took an oral hygiene education and were invited to give paraffin-stimulated saliva, and blood samples in the Diabetic Center. All patients were examined clinically and the results of the intraoral examination were recorded. During the intervention period of 30 nights, the participants were asked to let one Dentoblis™ or placebo lozenge slowly melt in their mouth for at least one minute before going to bed and after tooth brushing. Dentoblis™, contains 4x 109 CFU/g S. salivarius M18 strain probiotic isolated from a healthy oral microbiota. Neither the investigators nor the subjects were aware of the contents of the lozenges except for the research nurse, who was also responsible for keeping the codes and information confidential until after the statistical calculations. At baseline and at the end of the 30 day- intervention period, all measurements were retested.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat Tokgoz,DDS,DrPH, Istanbul University
- Investigators
- Yeliz Mercan, PhD, Principal investigator, Kırklareli University, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04913909
- Sponsor's protocol ID
- Project No. TDK-2016-20104
- Status last verified
- May 2021
- First submitted
- 22 May 2021
- Last updated
- 4 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- Individual data sharing
- Yes: All information will be available to share with other researchers
Publications
Burton JP, Drummond BK, Chilcott CN, Tagg JR, Thomson WM, Hale JDF, Wescombe PA. Influence of the probiotic Streptococcus salivarius strain M18 on indices of dental health in children: a randomized double-blind, placebo-controlled trial. J Med Microbiol. 2013 Jun;62(Pt 6):875-884. doi: 10.1099/jmm.0.056663-0. Epub 2013 Feb 28.
PubMed 23449874Soderling E, Hirvonen A, Karjalainen S, Fontana M, Catt D, Seppa L. The effect of xylitol on the composition of the oral flora: a pilot study. Eur J Dent. 2011 Jan;5(1):24-31.
PubMed 21311610
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Probiotic Streptococcus Salivarius Strain M18 on Oral Microbiota and Glycemic Control in Patients With Type 2 Diabetes Mellitus; A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04913909
- Acronym / sponsor ID
- Project No. TDK-2016-20104
- Conditions
- Diabetes Mellitus,Type 2, Periodontitis
- Keywords
- Probiotics, Diabetes mellitus, Oral microbiota, Periodontitis, Streptococcus salivarius M18
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 10 Sep 2015 (actual)
- Primary completion
- 18 May 2017 (actual)
- Study completion
- 14 Mar 2018 (actual)
- First posted
- 4 Jun 2021 (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 present study evaluated clinically the effects of a probiotic on oral microbiota and glycemic control in T2 diabetic patients with periodontal disease. The study was designed as a prospective randomized, double-blind, placebo- controlled interventional study. At baseline and at the end of the 30 day- probiotic period, all clinical, microbiological, and biochemical measurements were tested. Colony counts of oral microbiota, blood fructosamine levels and CRP were the outcomes of the study.
Detailed description
Objectives: To investigate the effects of an oral probiotic use, containing 4 billion colony forming unit (CFU/g) Streptococcus Salivarius M18 strain (Dentoblis™), on the quantities of oral microbiota in saliva and metabolic markers of T2 diabetics such as fructosamine, C-reactive protein (CRP).
Materials and Methods: The trial was designed as a prospective randomized, double-blind, placebo- controlled interventional study. Participants were selected from type 2 diabetics with periodontitis and aged 30-65 years, who presented to the Diabetic Center in Istanbul. Totally 70 patients were randomly assigned to probiotic or placebo groups. At baseline and at the end of the 30 day-probiotic period, colony counts of oral microbiota and biochemical measurements of diabetes were assessed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The trial was a prospective randomized, double-blind, placebo-controlled intervention study. All patients took an oral hygiene education and were invited to give paraffin-stimulated saliva, and blood samples in the Diabetic Center. All patients were examined clinically and the results of the intraoral examination were recorded. During the intervention period of 30 nights, the participants were asked to let one Dentoblis™ or placebo lozenge slowly melt in their mouth for at least one minute before going to bed and after tooth brushing. Dentoblis™, contains 4x 109 CFU/g S. salivarius M18 strain probiotic isolated from a healthy oral microbiota. Neither the investigators nor the subjects were aware of the contents of the lozenges except for the research nurse, who was also responsible for keeping the codes and information confidential until after the statistical calculations. At baseline and at the end of the 30 day- intervention period, all measurements were retested.
| Arm | Type | Receives |
|---|---|---|
| Dentoblis™ group | Active comparator | Dietary Supplement: Effects of an oral probiotic or placebo use on oral microbiota and glycemic index in Type 2 diabetic patientsIn Probiotic group; Dentoblis™, as a test lozenge, contains 4 billion CFU/g S. salivarius M18 strain probiotic isolated from a healthy oral microbiota, has been utilized one lozenge a day for 30 days. |
| Placebo group | Placebo comparator | Dietary Supplement: Effects of an oral probiotic or placebo use on oral microbiota and glycemic index in Type 2 diabetic patientsThe placebo was indistinguishable in form, size, color, smell and taste from the probiotic lozenge, but contained no bacteria and utilized one lozenge a day for 30 days . Placebo and probiotic lozenges were equivalent to 810 mg each and containing same amount of xylitol. Both were provided by the manufacturer, Bluestone Pharma GmbH, Baar, Switzerland, in equal white containers boxes, separated by production code. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- being diagnosed with T2 diabetes with <10% HbA1C for at least 6 months,
- 30-65 years old patients,
- high caries activity patients with Periodontal Disease Index (PDI) scores of 2, 3, 4 and 5,
- provision of written informed consent -
Key exclusion criteria (7 listed)
- patients regularly using probiotics,
- patients on corticosteroid, non-steroid anti-inflammatory, antibiotic or antibacterial mouthwash therapy,
- patients with multi-organ deficiency such as liver or kidney failure,
- patients with Immunodeficiency syndrome or on immunosuppressive therapy,
- patients with heart valve prosthesis or central venous catheter,
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 |
|---|---|---|
| Effects of an oral probiotic or placebo use on oral microbiota and glycemic index in Type 2 diabetic patientsThe participants were randomized to the interventional groups, probiotic or placebo, by the diabetes nurse. During the intervention period of 30 nights, the participants were asked to let one Dentoblis™ or placebo lozenge slowly melt in their mouth for one minute before going to bed and after tooth brushing. Dentoblis™, as a test lozenge, contains 4x109 CFU/g S. salivarius M18 strain isolated from a healthy oral microbiota and has been utilized as oral probiotic inhibiting dental caries-causing pathogens. The placebo is indistinguishable in form, size, color, and taste from the probiotic lozenge, but contains no bacteria. Placebo and probiotic lozenges were equivalent to 810 mg each and containing same amount of xylitol. Both were provided by the manufacturer, Bluestone Pharma GmbH, Baar, Switzerland, in equal white containers boxes, separated by production code. Neither the investigators nor the subjects were aware of the contents of the lozenges except for the research nurse. | Dietary supplement | Dentoblis™ group, Placebo group |
Primary outcome
Change in the Oral Microbiota colony counts at baseline and after intervention
Time frame: 30 days
Colony counts of periodontal pathogens, S.mutans and candidas were determined 30 day after the use of the Probiotic in CFU/g
Change in blood fructosamine levels in Type 2 diabetic patients an Oral probiotic use
Time frame: 30 days
Clinical marker of Type 2 diabetics such as CRP and fructosamine were determined 30 day after the use of the Probiotic
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 4 Jun 2021.
- Background: PubMed 23449874Burton JP, Drummond BK, Chilcott CN, Tagg JR, Thomson WM, Hale JDF, Wescombe PA. Influence of the probiotic Streptococcus salivarius strain M18 on indices of dental health in children: a randomized double-blind, placebo-controlled trial. J Med Microbiol. 2013 Jun;62(Pt 6):875-884. doi: 10.1099/jmm.0.056663-0. Epub 2013 Feb 28.
- Background: PubMed 21311610Soderling E, Hirvonen A, Karjalainen S, Fontana M, Catt D, Seppa L. The effect of xylitol on the composition of the oral flora: a pilot study. Eur J Dent. 2011 Jan;5(1):24-31.
- Individual participant dataSharing planned: Yes. All information will be available to share with other researchers
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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.
Yeliz Mercan, PhD principal investigator
Kırklareli University, Turkey
Questions about this trial
What is this clinical trial studying?
A study of Diabetes Mellitus,Type 2 and Periodontitis, run by Istanbul University.
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 4 inclusion and 7 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 4 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in the Oral Microbiota colony counts at baseline and after intervention (time frame: 30 days). The study lists 2 primary outcomes in all. 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 NCT04913909, 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 4 Jun 2021.