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临床试验/NCT06261515
NCT06261515招募中不适用

Multi-omics Multi-specimens Evaluation of Oral-gut-systemic Profiles in Patients With Stage III-IV Periodontitis Pre- and After-therapy

University of Turin, Italy2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年2月15日最近更新:
适应症

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

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)

研究者

发起方
University of Turin, Italy
申办方类型
Other
责任方
Sponsor

研究点 (2)

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