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

Periodontitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04913909
• Other study ID #: Project No. TDK-2016-20104
• Status: Completed
• Phase: N/A
• Start date: September 10, 2015
• Est. completion date: March 14, 2018

Study information

• Verified date: May 2021
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 14, 2018
• Est. primary completion date: May 18, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes Mellitus,Type 2
• Periodontitis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

References & Publications (2)

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. — View Citation

Söderling E, Hirvonen A, Karjalainen S, Fontana M, Catt D, Seppä L. The effect of xylitol on the composition of the oral flora: a pilot study. Eur J Dent. 2011 Jan;5(1):24-31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	30 days
Primary	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	30 days