Evaluation of Skin, Colonic, and Oral Microbiome and Effect of Time and Antibiotic Treatment on Organism Diversity at Each Site
Condition: BMI; General Demographics Characteristics
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.
    

Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        In Hojancha, region of Guanacaste, Costa Rica, where our study will be conducted, a
        population based census was completed in March 2009 and will serve as the basis for
        enrollment, allowing for recruitment of a representative sample of the population. Eligible
        participants must be willing to return for one follow- up visit: 6 months after the initial
        enrollment visit and willing to allow submission of blood for assays of serum immune
        markers, host genetic susceptibility and environmental factors, and to provide consent for
        use of the specimens. Those individuals with any known medical conditions that may limit
        life expectancy in the short term (including but not @@@limited to: congestive heart
        failure, renal failure, prior malignancy, or any other chronic disease that limits
        functional status to the extent that the individual cannot perform light work or the usual
        activities of daily self care) are ineligible for inclusion in the study. Female
        participants must not be pregnant.@@@
      
Keywords: Microbiome; Samples