Effects of a Probiotic on Oral Microbiota and Glycemic Control in Type 2 Diabetics; 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.

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Key information

Conditions

Diabetes Mellitus,Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Mouth Diseases Nutritional and Metabolic Diseases Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Dietary 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.

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study 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

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2018
First posted: Jun 4, 2021
Registry last updated: Jun 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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