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

Istanbul University

Status: Completed

Conditions: Periodontitis; Diabetes Mellitus,Type 2

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04913909

Project No. TDK-2016-20104

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 2 patient groups, including a placebo group

Dentoblis™ group

Active Comparator group

Description:

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.

Treatment:

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 group

Description:

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.

Treatment:

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