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NCT00852124 · ClinicalTrials.gov registry record · Phase 1
Safety of VSL#3 in Adult Asthmatics
A Phase 1 study, sponsored by University of Maryland, Baltimore.
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT00852124 is a Phase 1 study that was terminated before completion, run by University of Maryland, Baltimore. The registered enrollment target is 3 participants.
The verdict
NCT00852124, a Phase 1 study, was terminated before completion, sponsored by University of Maryland, Baltimore.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
We are proposing to test the safety of the probiotic, VSL#3, in a placebo controlled double blind safety study in 30 asthmatic adults. This adult safety trial was requested by the FDA IND review of a pediatric asthma protocol. Adults with a doctor diagnosis of persistent asthma will take VSL#3 or placebo twice daily for 3 months. Data will be collected, including age, race, height, and weight, present medications, past medical history with emphasis on signs/symptoms of asthma. On visits to the clinic we will evaluate * Changes in lung function * Intestinal permeability * Intestinal bacteria * Levels of inflammation in the blood * Women will have repeat urine pregnancy testing at each clinic visit
Interventions
- BIOLOGICAL VSL#3
- BIOLOGICAL VSL#3 or placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2007-02 |
| Est. Completion | 2013-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00852124
The ClinicalTrials.gov registry entry for NCT00852124 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Maryland, Baltimore, which has 560 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which VSL#3 is the first listed.
NCT00852124 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00852124 about?
NCT00852124 is a clinical study titled "Safety of VSL#3 in Adult Asthmatics". We are proposing to test the safety of the probiotic, VSL#3, in a placebo controlled double blind safety study in 30 asthmatic adults. This adult safety trial was requested by the FDA IND review of a pediatric asthma protocol. Adults with a doctor diagnosis of persistent asthma will take VSL#3 or p...
What is the current status of trial NCT00852124?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2007-02. Estimated completion is 2013-01.
What interventions are being tested in trial NCT00852124?
The interventions under investigation include: VSL#3 (BIOLOGICAL), VSL#3 or placebo (BIOLOGICAL).
Who is sponsoring clinical trial NCT00852124?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
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