Multi-omics Multi-specimens Evaluation of Oral-gut-systemic Profiles in Patients With Stage III-IV Periodontitis Pre- and After-therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Changes in gut microbial profile measured in stool samples
研究概览
简要总结
Periodontitis is a chronic inflammatory disease of the tooth supporting structures induced by a dysbiosis in the oral and subgingival microenvironment of susceptible patients. The long-term swallowing of high doses of periodontal pathogenic microorganisms could induce a dysbiosis of the intestinal microbiota, favouring the establishment of an 'inflamed' microbiome in terms of composition and/or function. The present project is aimed at a better understanding of the etiopathogenetic correlation between periodontitis and intestinal dysbiosis, and aims to explore the hypothesis that periodontal treatment may influence the multi-omics profile on the oral-gut-systemic axis. 70 patients affected by stage III-IV periodontitis will be recruited, and treated by means of full-mouth scaling and root planing. Salivary, subgingival plaque, plasma and stool samples, together with a complete periodontal charting and a food diary will be collected and compared at baseline and after treatment. Age, gender and BMI-matched healthy individuals will be recruited as controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •periodontitis Stage III or IV
- •BMI between 20 and 29 kg/m2
- •free diet
- •presence of at least 20 teeth
排除标准
- •systemic diseases (including diabetes, thyroid, liver, or kidney diseases)
- •dietary allergies
- •use of antibiotics or probiotics during the previous 90 days
- •pregnancy or breast feeding
结局指标
主要结局
Changes in gut microbial profile measured in stool samples
时间窗: Baseline and 90 days
Taxonomic variation of gut bacteria concentration after treatment assessed through shotgun metagenomics
Changes in oral microbial profile measured in saliva samples
时间窗: Baseline and 90 days
Taxonomic variation of salivary bacteria concentration after treatment assessed through shotgun metagenomics
Changes in oral microbial profile measured in subgingival plaque samples
时间窗: Baseline and 90 days
Taxonomic variation of subgingival bacteria concentration after treatment assessed through shotgun metagenomics
次要结局
- Changes in oral-gut metabolome measured in stool samples(Baseline and 90 days)
- Changes in oral-gut miRNAome measured in stool samples(Baseline and 90 days)
- Metabolic plasma changes(Baseline and 90 days)
