Clinical trial NCT04913909: Effects of a Probiotic on Oral Microbiota and Glycemic Control in Type 2 Diabetics; A Randomized 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus,Type 2
Periodontitis
Keywords: Probiotics
Diabetes mellitus
Oral microbiota
Periodontitis
Streptococcus salivarius M18
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2021-06-04
Enrollment: 70
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The trial was a prospective randomized, double-blind, placebo-controlled intervention study.

All patients took an oral hygiene education and were invited to give paraffin-stimulated saliva, and blood samples in the Diabetic Center. All patients were examined clinically and the results of the intraoral examination were recorded. During the intervention period of 30 nights, the participants were asked to let one Dentoblis™ or placebo lozenge slowly melt in their mouth for at least one minute before going to bed and after tooth brushing. Dentoblis™, contains 4x 109 CFU/g S. salivarius M18 strain probiotic isolated from a healthy oral microbiota.

Neither the investigators nor the subjects were aware of the contents of the lozenges except for the research nurse, who was also responsible for keeping the codes and information confidential until after the statistical calculations. At baseline and at the end of the 30 day- intervention period, all measurements were retested.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in the Oral Microbiota colony counts at baseline and after intervention
timeFrame: 30 days
measure: Change in blood fructosamine levels in Type 2 diabetic patients an Oral probiotic use
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Kırklareli University, Turkey
name: Yeliz Mercan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Soderling E, Hirvonen A, Karjalainen S, Fontana M, Catt D, Seppa L. The effect of xylitol on the composition of the oral flora: a pilot study. Eur J Dent. 2011 Jan;5(1):24-31.