Completed

Streptococcus Salivarius M18 Probiotic Impact on Oral Microbiota and Glycemic Control in Type 2 Diabetes

Study Aim

This study aims to evaluate the impact of Streptococcus Salivarius M18 probiotic on oral microbiota and glycemic control in individuals with Type 2 Diabetes, by observing changes in blood fructosamine levels and oral microbiota colony counts after 30 days of probiotic use.

What is being tested

Effects of an oral probiotic or placebo use on oral microbiota and glycemic index in Type 2 diabetic patients

Dietary Supplement

Who is being recruted

Diabetes Mellitus+7

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

From 30 to 65 Years

+11 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Supportive Care Study

Placebo-Controlled

Interventional

Study Start: September 2015

See protocol details

Summary

Principal SponsorIstanbul University

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: September 10, 2015

Actual date on which the first participant was enrolled.

This study focuses on the impact of a specific probiotic, Streptococcus Salivarius M18 strain (Dentoblis™), on the oral health and blood sugar control of individuals with type 2 diabetes. The research aims to understand how this probiotic affects the balance of bacteria in the mouth and certain diabetes-related markers, like fructosamine and C-reactive protein (CRP). The study involves individuals aged 30 to 65 who have both type 2 diabetes and periodontitis, a common gum disease. The goal is to explore if this probiotic can improve oral health and diabetes management, addressing a potential gap in care for those with these conditions. During the study, participants are randomly assigned to either a probiotic or a placebo group. The probiotic is given orally and contains 4 billion colony forming units (CFU/g) of the Streptococcus Salivarius M18 strain. Over a 30-day period, changes in the quantity of oral bacteria and diabetes-related markers are measured and compared. The primary outcomes include changes in blood fructosamine levels and shifts in the colony counts of specific oral bacteria. These measurements help researchers understand the potential benefits and risks of using this probiotic for managing type 2 diabetes and periodontitis.

Official TitleEffects of Probiotic Streptococcus Salivarius Strain M18 on Oral Microbiota and Glycemic Control in Patients With Type 2 Diabetes Mellitus; A Randomized Clinical Trial

NCT04913909

Principal SponsorIstanbul University

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

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

Design Details

70 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 30 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesStomatognathic DiseasesMouth DiseasesNutritional and Metabolic DiseasesPeriodontal DiseasesPeriodontitisGlucose Metabolism Disorders

Criteria

4 inclusion criteria required to participate

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 -

7 exclusion criteria prevent from participating

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,

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

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.

Group II

Placebo

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.

Study Objectives

Primary Objectives

Study Centers

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CompletedNo study centers