Effects of a Probiotic on Oral Microbiota and Glycemic Control in Type 2 Diabetics; A Randomized Clinical Trial

May 30, 2021 updated by: Murat Tokgoz,DDS,DrPH, Istanbul University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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 -

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dentoblis™ group
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.
Dietary supplement: Effects of an oral probiotic or placebo use on oral microbiota and glycemic index in Type 2 diabetic patients

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.
Placebo Comparator: Placebo group
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.
Dietary supplement: Effects of an oral probiotic or placebo use on oral microbiota and glycemic index in Type 2 diabetic patients

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 days
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
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Investigators

  • Principal Investigator: Yeliz Mercan, PhD, Kırklareli University, Turkey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2015

Primary Completion (Actual)

May 18, 2017

Study Completion (Actual)

March 14, 2018

Study Registration Dates

First Submitted

May 22, 2021

First Submitted That Met QC Criteria

May 30, 2021

First Posted (Actual)

June 4, 2021

Study Record Updates

Last Update Posted (Actual)

June 4, 2021

Last Update Submitted That Met QC Criteria

May 30, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Project No. TDK-2016-20104

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All information will be available to share with other researchers

IPD Sharing Time Frame

As of January 2022

IPD Sharing Access Criteria

No criteria

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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