Trial Information

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

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.