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临床试验/NCT01143571
NCT01143571已完成不适用

Evaluation of Skin, Colonic and Oral Microbiota and Effect of Time and Antibiotic Treatment on Organism Diversity at Each Site

National Cancer Institute (NCI)1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2009年11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
150
试验地点
1
主要终点
microbiome heterogeneity

研究概览

简要总结

Background:

  • Most studies of infectious agents have focused on specific microbes, such as human papillomaviruses and cervical cancer, and the hepatitis B and C virus and liver cancer. The skin and many internal areas (including the mouth and the gastrointestinal tract) also contain large numbers of naturally occurring microbes, but these areas have not received as much study.
  • Some of the infectious agents that naturally reside in the body may have an effect on health. The study of naturally occurring microbes in the human body is a new area of research, and much remains to be learned regarding the extent and pattern of their appearance and appropriate techniques for testing them.
  • Researchers are interested in collecting human samples from areas known to contain naturally occurring microbes. These samples will provide baseline information for further studies.

Objectives:

  • To collect a set of study samples from individuals who have applied to participate in a study assessing the relationship among the bacteria H. pylori, peptic ulcer disease, and gastric cancer.

Eligibility:

  • Individuals between the ages of 21 and 65 who are participating in the clinical trial entitled A Phase III Randomized Trial of Three Antibiotic Regimens to Eradicate Helicobacter Pylori.

Design:

  • Researchers will collect oral (saliva), colonic, and skin swab samples from study participants who tested positive for the presence of the H. pylori bacteria. These samples will be collected at the three study visits (enrollment, 6 weeks, and 1 year).
  • Researchers will also collect samples from people who applied for the clinical trial but did not test positive for H. pylori. These samples will be collected at the enrollment visit and 1 year later.
  • Blood samples will be collected at each study visit.

详细描述

The study of infectious agents and their role in disease is not new. Most efforts in this area have focused on specific agents, such as human papillomaviruses and cervical cancer, Helicobacter pylori (HP) and gastric diseases and carcinoma, hepatitis B and C virus and liver cancer, to name a few. The body s skin and mucosal surface s play host to microbial communities (the microbiome) whose membership outnumbers our own somatic and germ cells by an order of magnitude or more. The skin, oral, and gastrointestinal (GI) tract are all densely colonized surfaces . Recent technological advances, however, have made exploration of the microbiome, an understudied area, feasible. It is reasonable to hypothesize that some of the infectious agents that naturally reside in the body may impact health, or that perhaps the balance between the various micro-organisms has an effect on health. This new field of study has much promise that could lead to important new discoveries of how infectious agents are associated with disease and how environmental (e.g., diet) and host responses (e.g., immune response and genetics) to these agents determine chronic patterns of colonization and subsequent disease risk.

However, because the study of the human microbiome is a new area of research, much remains to be learned regarding: a) the extent and pattern of the microbiome at various sites, b) determinants of these patterns (e.g., consistency over time), and c) optimal assay techniques.

Prior to launching large-scale epidemiological studies to evaluate the association between microbiome and disease (including cancer), it is crucial to conduct well-designed, systematic, methodological studies to address some of the issues listed above. These methodological studies will begin to provide the baseline information that could be used to plan for, and conduct disease association studies.

We propose to initiate a study to collect oral, skin, vaginal (only women), penile (men only) and colonic samples at enrollment and again 6 months later on up to 150 individuals. Our objectives are:

  1. To evaluate the microbiome heterogeneity between individuals across specimen types - colonic/oral/skin/vaginal/penile.
  2. To evaluate the microbiome heterogeneity within individuals (over time and across specimen types - colonic/oral/skin/vaginal/penile).
  3. To evaluate the effect of self-reported antibiotic treatment on the oral, colonic, skin, penile and vaginal microbiomes diversity and richness.
  4. To evaluate the associations between colonic microbiome and gastrointestinal symptom disorders (assessed by the Rome III questionnaire - a detailed diagnostic questionnaire for adult functional gastrointestinal disorder), inflammatory markers (initially using measures of C-reactive protein (CRP)), and demographic factors.
  5. To evaluate the reproducibility of assays used to measure the microbiota and compare the diversity and abundance determined by the different assays.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

microbiome heterogeneity

时间窗: 6 months

To evaluate the microbiome heterogeneity between and within individuals across specimen types

次要结局

未报告次要终点

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (1)

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