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

NCT01143571 | Completed

• 2 other identifiers: 99991001810-C-N018
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

BMI; General Demographics Characteristics

Keywords

Microbiome; Samples

Outcome Measures

Primary Outcomes (1)

• microbiome heterogeneity

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

  6 months

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.@@@

* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Proyecto Epidemiologico in Hohancha

Hojancha, Costa Rica

Location

Related Publications (3)

• 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.

  PMID: 12589864 BACKGROUND

• 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.

  PMID: 16404738 BACKGROUND

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

  PMID: 11902583 BACKGROUND

Study Officials

• Emily J Vogtmann, Ph.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2010
• First Posted: June 14, 2010
• Study Start: November 20, 2009
• Last Updated: June 11, 2020

Record last verified: 2019-06-18

Locations

CO (1)