Status:
TERMINATED
Point-of-Use Pathogen Identification Tool for Diarrhea
Lead Sponsor:
National Institute of Nursing Research (NINR)
Conditions:
Diarrhea
Eligibility:
All Genders
Brief Summary
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 w...
Detailed Description
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 disea...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- 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.
- Current enrollment in an active NIH protocol or enrollment in 12-NR-0195.
- Able to provide 50ml stool sample within 2-3 hours.
- Children will only be enrolled if they are currently enrolled in an active NIH protocol or enrolled in 12-NR-0195.
- EXCLUSION CRITERIA:
- This protocol will exclude outpatients who are clinically unstable patients. Clinically unstable patient is defined as someone requiring emergent care or hospitalization.
- Antibiotic use, which can affect intestinal flora, is not exclusionary but will be controlled for via post-hoc analysis.
- NINR employees, subordinates/relatives/ or co-workers.
- Any NIH employee who is a subordinates/relatives/or co-workers of study investigator.
Exclusion
Key Trial Info
Start Date :
February 14 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 23 2019
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT03394040
Start Date
February 14 2019
End Date
December 23 2019
Last Update
January 6 2020
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892