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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: Completed Phase 1 study, sponsored by Johns Hopkins Bloomberg School of Public Health.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00198796 record still lists
NCT00198796 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which H10407 is the first listed.
NCT00198796 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00198796's enrollment target sits among peer trials
5 1989th of 2000 higher than 6 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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