Obtaining and Storing Human Blood, Urine, and Fecal Samples for Spirochete-Related Epidemiological Research

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-12-31

Brief Summary

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Current spirochaete infection identification and diagnostic strategies have important limitations. Recent development may allow for an improvement in diagnostic, screening and survey capabilities. The goal of this study is to evaluate blood, urine and fecal samples from a variety of sources and generate information on the occurrence and epidemiology of spirochetes in the general and at risk populations.

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Detailed Description

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The intent of this protocol is to obtain blood, feces and urine samples from subjects with or without a suspected spirochaete infection, so these samples can be used in spirochaete-related scientific studies.

Conditions

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The Samples Will be Studied in Order to Attempt to Better Understand the Occurrence of Blood, Feces and Urine Borne Spirochaetes

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. The subject must be able to be fully consented to the study.
2. The subject must be 18 years of age or older.
3. The subject must be mentally competent as determined by the Investigator.

Exclusion Criteria

1. The subject must not be currently incarcerated or pregnant.
2. The subject must not weigh less than 110lbs.
3. If the subject will be contributing more that 60 ml of blood during an 8 (eight) week period, then the subject must not have donated red blood cells within the last 8 (eight) weeks.
4. If the Subject's health would be compromised by contributing up to 30ml of peripheral blood.
5. If in the opinion of the Investigator, the subject has any clinically significant medical diagnosis/conditions which would prevent participation.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No