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

NCT04913909 | Completed DMC

• 1 other identifier: Project No. TDK-2016-20104
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus,Type 2; Periodontitis

Keywords

Probiotics; Diabetes mellitus; Oral microbiota; Periodontitis; Streptococcus salivarius M18

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Dentoblis™ group

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.

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

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.

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

Interventions

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.

Dentoblis™ group; Placebo group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• being diagnosed with T2 diabetes with \<10% HbA1C for at least 6 months,
• years old patients,
• high caries activity patients with Periodontal Disease Index (PDI) scores of 2, 3, 4 and 5,
• provision of written informed consent -

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University: lead

Related 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.

  PMID: 23449874 BACKGROUND

• 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.

  PMID: 21311610 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Periodontitis; Diabetes Mellitus

Interventions

Glycemic Index

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Nutritive Value; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Food Quality; Food Technology; Food Industry; Industry; Technology, Industry, and Agriculture; Public Health; Environment and Public Health

Study Officials

• Yeliz Mercan, PhD

  Kırklareli University, Turkey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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. Statistical analysis were performed by a blind assessor.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: 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.

Study Record Dates

• First Submitted: May 22, 2021
• First Posted: June 4, 2021
• Study Start: September 10, 2015
• Primary Completion: May 18, 2017
• Study Completion: March 14, 2018
• Last Updated: June 4, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: As of January 2022
• Access Criteria: No criteria