Point-of-Use Pathogen Identification Tool for Diarrhea
Point-of-Use Pathogen Identification Tool for Diarrhea
Background:

 Many people suffer from diarrhea every year. In the United States, it leads to about 130,000
 hospitalizations and 3,000 deaths a year. Researchers want to test a tool that may show them
 what germs cause diarrhea. It is a simple paper strip test and doesn t require electric
 power. This may make it easier for health care workers to more quickly fight diarrheal
 diseases.

 Objective:

 To test a tool that may detect what germs cause diarrhea.

 Eligibility:

 People already enrolled in an active NIH protocol who have diarrhea

 Design:

 Participants will have 1 or 2 studies. They will give information about their symptoms,
 current medicines, and basic personal data. They will give a stool sample.

 Part of each sample will be tested in a lab. The rest will be stored indefinitely. No
 personal data will be connected to the samples. The stored samples may be used in future
 research.

 Positive test results will be reported to a participant s primary doctor
Objective

 This is a cross-sectional study to validate a new, simple, rapid and affordable point-of-use
 pathogen identification research tool (hence forth referred to as the "tool") of diarrheal
 diseases for potential use in resource limited settings in the future. The tool was developed
 under the terms of a National Institutes of Health (NIH) approved Clinical CRADA between NINR
 and GoDx, Inc. The sensitivity and specificity of the tool in identifying several common
 gastrointestinal (GI) pathogens in stool will be examined in participants with diarrhea. The
 proposed validation study will constitute the initial assessment of the tool in a healthcare
 environment. Once the detection validity and technical performance of the tool have been
 evaluated in this context, the tool will be further tested in low resource healthcare
 settings.

 Study population

 Study participants will be recruited from the Washington, DC, metropolitan area using
 standard NIH recruitment practices, as well as from among participants in two existing
 protocols (09-NR-0064, 12-NR-0195) which recruit and consent research participants with GI
 disorders and diseases. Lastly, participants enrolled on other NIH protocols will be
 recruited. Appropriate stool samples may also be sequestered from an exempt repository
 protocol (09-NR-N228). All ages, ethnicities and both sexes will be considered for inclusion
 in this study. The study population would reflect the demographics of the greater Washington
 DC metropolitan area. Externally recruited participants and participants recruited from
 existing protocols will be asked to supply stool samples. A total of 800 samples from
 participants with diarrhea will be included in this study.

 Design

 Stool samples will be collected from participants with diarrhea for which pathogen testing
 using the NIH standard of care, BioFire FilmArray GI Pathogen Panel (FDA approved PCR based
 pathogen diagnostic) by the Department of Laboratory Medicine (DLM) is indicated. Collected
 stool samples will be tested for pathogens causing GI disease, using the FilmArray GI panel
 by the DLM. Technicians in the NINR laboratories will test aliquots from the same stool
 samples using our tool. The tool has been designed for detection of the most common diarrhea
 causing pathogens. Of primary interest for this study are: Enteropathogenic Escherichia coli
 - EPEC, Clostridium difficile C. difficile, Enteroaggregative Escherichia coli - EAEC, and
 Campylobacter spp. Pathogens of secondary interests, but for which the study is not
 specifically powered, will also be included and are: Shigella sp., Shiga Toxin-Producing
 Escherichia coli - STEC, Salmonella spp., and Cryptosporidium spp. Participants will not
 receive results from the tool.

 Outcome measures

 The percent sensitivity (ability to make the correct positive identification), specificity
 (ability to make the correct negative identification) and 95% confidence intervals will be
 statistically determined by comparing the results yielded by the tool and the FilmArray GI
 panel. Controlled laboratory experiments suggest >90% specificity and sensitivity of the tool
 for the detection of the specified pathogens.
-  INCLUSION CRITERIA:

 1. We will include samples from participants with self-reported or clinical provider
 documented diarrhea defined as one or more loose or watery stools per day as
 defined by criteria a or b below:

 -  Cases of acute diarrhea (i.e., diarrhea which is currently active or was
 experienced up to one day prior to sampling or still active during sampling)
 will be included.

 -  Cases of persistent diarrhea (i.e., diarrhea which is chronic or
 chronic-intermittently, i.e., once a week or more, experienced for at least
 2 to 4 weeks prior to sampling), will be included. In the case of chronic
 diarrhea, diarrhea does not have to be active on the day of, or immediately
 prior to (i.e., one day) sampling.

 2. Current enrollment in an active NIH protocol or enrollment in 12-NR-0195.

 3. Able to provide 50ml stool sample within 2-3 hours.

 4. Children will only be enrolled if they are currently enrolled in an active NIH
 protocol or enrolled in 12-NR-0195.

 EXCLUSION CRITERIA:

 1. This protocol will exclude outpatients who are clinically unstable patients.
 Clinically unstable patient is defined as someone requiring emergent care or
 hospitalization.

 2. Antibiotic use, which can affect intestinal flora, is not exclusionary but will be
 controlled for via post-hoc analysis.

 3. NINR employees, subordinates/relatives/ or co-workers.

 4. Any NIH employee who is a subordinates/relatives/or co-workers of study investigator.