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BMINCT01143571

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

An observational study of BMI and General Demographics Characteristics, run by National Cancer Institute (NCI) at 1 site in Costa Rica.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
BMI, General Demographics Characteristics
How many people
150 participants
Where
1 siteCosta Rica
Study dates
20 Nov 2009to not given
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.@@@

  • ELIGIBILITY CRITERIA:

Individuals who meet the age criteria of 18 years and older and are interested in the study will be asked to provide written informed consent. Participants must be willing to reside in the study area for the study duration (6 months). 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.

Individuals who report recent antibiotic use will be deferred and enrolled after they have been at least 6 weeks without antibiotic use.

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. The same census was used to identify participants for another study in the same area. Therefore, because we will use the same census, we will exclude participants that were enrolled in the other study. 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.

Trial locations and contacts

1 site in 1 country.

Costa Rica1 site

  • Proyecto Epidemiologico in Hohancha

    Hojancha

Other trials in Costa Rica

About this study

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

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.
Read more

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.
Read the 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.
Keywords
Microbiome, Samples

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. microbiome heterogeneity

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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2010 (estimated)
  2. Study start20 Nov 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Prospective
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01143571
Sponsor's protocol ID
999910018
Other IDs
10-C-N018
Status last verified
18 Jun 2019
First submitted
11 Jun 2010
Last updated
11 Jun 2020
Results posted
No

Publications

  • Kelley JR, Duggan JM. Gastric cancer epidemiology and risk factors. J Clin Epidemiol. 2003 Jan;56(1):1-9. doi: 10.1016/s0895-4356(02)00534-6.

    PubMed 12589864

  • Parkin DM. The global health burden of infection-associated cancers in the year 2002. Int J Cancer. 2006 Jun 15;118(12):3030-44. doi: 10.1002/ijc.21731.

    PubMed 16404738

  • Peek RM Jr, Blaser MJ. Helicobacter pylori and gastrointestinal tract adenocarcinomas. Nat Rev Cancer. 2002 Jan;2(1):28-37. doi: 10.1038/nrc703.

    PubMed 11902583

Questions about this trial

What is this clinical trial studying?

An observational study of BMI and General Demographics Characteristics, run by National Cancer Institute (NCI) at 1 site in Costa Rica.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Costa Rica. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

microbiome heterogeneity (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01143571, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.

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