Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 2 study that has completed, run by Johns Hopkins Bloomberg School of Public Health. The registered enrollment target is 36 participants.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00524004
The ClinicalTrials.gov registry entry for NCT00524004 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 36 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 3 interventions - of which Placebo is the first listed.
NCT00524004 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.