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

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.

Study Overview

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

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 35

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Blood, feces and urine samples may be collected from subjects with known or suspected spirochetal disease or from subjects not suspected to be infected with spirochetes

Description

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.

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Southwest Regional Wound Care Center

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (ACTUAL): December 1, 2010
• Study Completion (ACTUAL): December 1, 2010

Study Registration Dates

• First Submitted: March 16, 2010
• First Submitted That Met QC Criteria: March 16, 2010
• First Posted (ESTIMATE): March 18, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): September 7, 2011
• Last Update Submitted That Met QC Criteria: September 6, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: human blood, urine and fecal samples
• Other Study ID Numbers: 56-RW-015