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临床试验/NCT04925700
NCT04925700已完成不适用

The Oral Microbiome in Oral Squamous Cell Carcinoma

University of Iowa2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年4月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Assessment of changes in the oral microbiome composition over time

研究概览

简要总结

Previous work by a number of scientific teams has revealed that the types of bacteria that colonize the mouth differ between health and pre-cancerous or cancerous oral lesions. The purpose of this study is to investigate the extent of these changes and to correlate the changes with alterations in the activities of the host's own oral tissues. In doing so, we believe we can gain a better understanding of how particular bacterial species, or consortia of species, can result in an individual having an increased risk of the most common type of oral cancer -- oral squamous cell carcinoma. This knowledge may also lead to the identification of salivary biomarkers that can be used for clinical evaluation or screening. In addition, we seek to determine the extent to which a probiotic regimen can help prevent or rectify the disease-related changes in the types of bacterial colonizing the mouth. The microbiome in health, pre-cancerous lesions, and cancerous lesions will be determined from remnant microbial DNA in banked tissue samples. The effects of probiotics on the oral microbiome will be determined from DNA collected from swabs of oral tissue at baseline and then after 3 to 6 months of probiotic usage.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
21 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults (21-70 years old) who have been diagnosed with oral dysplasia or that have been treatment-planned as wait and watch or
  • Adults (21-70 years old) or who have been diagnosed with oral squamous cell carcinoma, or matched healthy controls free of any oral lesions

排除标准

  • Adults who have had a course of antibiotics that was completed less than 3 months prior to the study;
  • Adults with any immunosuppressive condition or medication that would put the subject at risk of consuming daily probiotics;
  • Adults who regularly use probiotic dietary supplements
  • Adults that have alcohol/tobacco use history that does not match study population - this if for the healthy controls arm only.

结局指标

主要结局

Assessment of changes in the oral microbiome composition over time

时间窗: Up to 3 months

16S Genomic Profiling will be done in all recruited subjects via oral swab of pre-cancerous or cancerous oral lesion

Determine the Effect of ProDentis on the Oral Microbiome

时间窗: Up to 3 months

Pre-Cancerous lesion is treatment planned as "watch-and-wait" or oral lesion is not present, recruited subjects will be randomly assigned to either the probiotic lozenge or placebo lozenge group.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David R. Drake

Professor

University of Iowa

研究点 (2)

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