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NCT00198796 · ClinicalTrials.gov registry record · Phase 1
Dose-finding Study of WS6788A, DS37-4 and H10407 Enterotoxigenic Escherichia Coli (ETEC) Challenge Strains
A Phase 1 study, sponsored by Johns Hopkins Bloomberg School of Public Health.
- Completed
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT00198796 is a Phase 1 study that has completed, run by Johns Hopkins Bloomberg School of Public Health. The registered enrollment target is 5 participants.
The verdict
NCT00198796, a Phase 1 study, has completed, sponsored by Johns Hopkins Bloomberg School of Public Health.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
Five subjects will be admitted to the General Clinical Research Center (GCRC). The next day they will eat a light breakfast, fast for 90 minutes, ingest ETEC strain H10407, and fast for 90 more minutes. After this challenge they will be monitored closely , and all stools will be collected, graded and weighed. On Day 5, or sooner if indicated, they will begin antibiotics to eradicate the challenge strain. They will be scheduled for discharge on Day 7 but may leave a few days earlier if early antibiotic treatment is given. Hypothesis: A challenge dose of 10(9) colony forming unit (CFU) of ETEC strain H10407, will cause diarrhea in at least 60% of subjects.
Interventions
- BIOLOGICAL H10407
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2005-09 |
| Est. Completion | 2007-05-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00198796
The ClinicalTrials.gov registry entry for NCT00198796 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins Bloomberg School of Public Health, which has 187 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which H10407 is the first listed.
NCT00198796 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00198796 about?
NCT00198796 is a clinical study titled "Dose-finding Study of WS6788A, DS37-4 and H10407 Enterotoxigenic Escherichia Coli (ETEC) Challenge Strains". Five subjects will be admitted to the General Clinical Research Center (GCRC). The next day they will eat a light breakfast, fast for 90 minutes, ingest ETEC strain H10407, and fast for 90 more minutes. After this challenge they will be monitored closely , and all stools will be collected, graded an...
What is the current status of trial NCT00198796?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2005-09. Estimated completion is 2007-05-30.
What interventions are being tested in trial NCT00198796?
The interventions under investigation include: H10407 (BIOLOGICAL).
Who is sponsoring clinical trial NCT00198796?
This trial is sponsored by Johns Hopkins Bloomberg School of Public Health, which has 187 total clinical trials registered on ClinicalTrials.gov.
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