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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: Clinical Trial Phase 1 study, sponsored by University of Maryland, Baltimore.
NCT00852124 is a Phase 1 study that was terminated before completion, run by University of Maryland, Baltimore. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Change in FEV in adult asthmatics receiving VSL3# as compared to controls receiving placebo.
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 |
Why NCT00852124 stopped before completion
NCT00852124 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which VSL#3 is the first listed.
NCT00852124 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00852124's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 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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