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NCT03511365 · ClinicalTrials.gov registry record · Phase 1
Effects of Probiotic on Inflammation and Microbiota in Patients With NASH
A Phase 1 study, sponsored by Northwell Health.
- Terminated
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT03511365: Clinical Trial Phase 1 study, sponsored by Northwell Health.
NCT03511365 is a Phase 1 study that was terminated before completion, run by Northwell Health. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03511365, a Phase 1 study, was terminated before completion, sponsored by Northwell Health.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
Individuals with clinically identified non-alcoholic fatty liver disease will undergo baseline evaluation of IL-17 and other inflammatory markers as well as microbiome determination. The probiotic formulation VSL#3 450 Billion CFU twice daily will be administered for 8 weeks and the determination of Il-17 and microbiome will be repeated. Each subject will serve as his or her own control.
Primary Outcome
Percent decrease in Il levels will be recorded.
Interventions
- BIOLOGICAL Probiotic Formulation VSL#3
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2018-05-15 |
| Est. Completion | 2019-10-11 |
| Phase | Phase 1 |
Why NCT03511365 stopped before completion
NCT03511365 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which Probiotic Formulation VSL#3 is the first listed.
NCT03511365 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03511365 about?
NCT03511365 is a clinical study titled "Effects of Probiotic on Inflammation and Microbiota in Patients With NASH". Individuals with clinically identified non-alcoholic fatty liver disease will undergo baseline evaluation of IL-17 and other inflammatory markers as well as microbiome determination. The probiotic formulation VSL#3 450 Billion CFU twice daily will be administered for 8 weeks and the determination of...
What is the current status of trial NCT03511365?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2018-05-15. Estimated completion is 2019-10-11.
What interventions are being tested in trial NCT03511365?
The interventions under investigation include: Probiotic Formulation VSL#3 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03511365?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03511365's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 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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