Effects of Probiotic Streptococcus Salivarius Strain M18 on Oral Microbiota and Glycemic Control in Patients With Type 2 Diabetes Mellitus; A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 主要终点
- Change in the Oral Microbiota colony counts at baseline and after intervention
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 -
排除标准
- •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.
结局指标
主要结局
Change in the Oral Microbiota colony counts at baseline and after intervention
时间窗: 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
时间窗: 30 days
Clinical marker of Type 2 diabetics such as CRP and fructosamine were determined 30 day after the use of the Probiotic
次要结局
未报告次要终点
研究者
Murat Tokgoz,DDS,DrPH
Researcher
Istanbul University