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NCT00524004 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Bovine Milk Immunoglobulin Against CS17 and CsbD
A Phase 2 study, sponsored by Johns Hopkins Bloomberg School of Public Health.
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
NCT00524004: Completed Phase 2 study, sponsored by Johns Hopkins Bloomberg School of Public Health.
NCT00524004 is a Phase 2 study that has completed, run by Johns Hopkins Bloomberg School of Public Health. The registered enrollment target is 36 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00524004, a Phase 2 study, has completed, sponsored by Johns Hopkins Bloomberg School of Public Health.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
Study Summary
This is a Phase II, randomized, double-blind, placebo-controlled study designed to investigate whether hyperimmune bovine milk IgG products specific for CsbD and CS17, protect subjects against diarrhea upon challenge with a CS-17-ETEC strain LSN03-016011/A. The study will also evaluate safety and tolerability of these bovine milk IgG products and describe the immune responses following challenge. The primary study objectives are: 1) Assess safety of the anti-CsbD and anti-CS17 bovine milk IgG among healthy adult volunteers when orally administered three times a day over 7 days. 2) Determine efficacy of the anti-CsbD bovine milk IgG preparation against ETEC diarrhea upon challenge with CS17-ETEC, and 3)Determine efficacy of the anti-CS17 bovine milk IgG preparation against ETEC diarrhea upon challenge with CS17-ETEC. A secondary objective is to determine efficacy of the anti-CsbD and anti-CS17 bovine milk IgG preparations against moderate to severe ETEC diarrhea upon challenge with CS17-ETEC.
Interventions
- OTHER Placebo
- BIOLOGICAL Anti-CsbD Bovine IgG
- BIOLOGICAL Anti-CS17 Bovin IgG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2007-01-30 |
| Est. Completion | 2007-10-26 |
| Phase | Phase 2 |
What the finished NCT00524004 record still lists
NCT00524004 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00524004 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00524004 about?
NCT00524004 is a clinical study titled "Safety and Efficacy of Bovine Milk Immunoglobulin Against CS17 and CsbD". This is a Phase II, randomized, double-blind, placebo-controlled study designed to investigate whether hyperimmune bovine milk IgG products specific for CsbD and CS17, protect subjects against diarrhea upon challenge with a CS-17-ETEC strain LSN03-016011/A. The study will also evaluate safety and to...
What is the current status of trial NCT00524004?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2007-01-30. Estimated completion is 2007-10-26.
What interventions are being tested in trial NCT00524004?
The interventions under investigation include: Placebo (OTHER), Anti-CsbD Bovine IgG (BIOLOGICAL), Anti-CS17 Bovin IgG (BIOLOGICAL).
Who is sponsoring clinical trial NCT00524004?
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 NCT00524004's enrollment target sits among peer trials
36 1496th of 2000 higher than 477 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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