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NCT04175392 · ClinicalTrials.gov registry record · Phase 1
Effect of Probiotics in Non-alcoholic Fatty Liver Disease and Steatohepatitis
A Phase 1 study, sponsored by Corewell Health East.
- Terminated
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT04175392: Clinical Trial Phase 1 study, sponsored by Corewell Health East.
NCT04175392 is a Phase 1 study that was terminated before completion, run by Corewell Health East. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04175392, a Phase 1 study, was terminated before completion, sponsored by Corewell Health East.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
This study will evaluate the effect of probiotics, a beneficial intestinal bacteria supplement, if it will cause improvement of the non-alcoholic fatty liver disease (NAFLD) and or non-alcoholic steatohepatitis (NASH- an inflammation with concurrent fatty accumulation of the liver) as measured by transient elastography - an ultrasound of the liver that assess the elastic properties (density) and stiffness of the liver tissue. This study will enroll patients 18 years and older with diagnosis of NAFLD and or NASH.
Primary Outcome
Probiotic effects on liver fibrosis as measured by transient elastography, as a change from baseline to 6 months, measured on a scale from 1-4. 1= a clinical grade of F0-F1 and represents 2-7 kilopascals in elastography testing. 4= a clinical grade of F4 and represents 14 kilopascals or higher in elastography testing. A higher score on the scale represents worsening liver scarring. Positive numbers indicate an increase in fibrosis; negative numbers indicate decrease in fibrosis.
Interventions
- DRUG Placebos
- DRUG Align Probiotic Supplement Capsule
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2021-01-12 |
| Est. Completion | 2022-03-01 |
| Phase | Phase 1 |
Why NCT04175392 stopped before completion
NCT04175392 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebos is the first listed.
NCT04175392 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04175392 about?
NCT04175392 is a clinical study titled "Effect of Probiotics in Non-alcoholic Fatty Liver Disease and Steatohepatitis". This study will evaluate the effect of probiotics, a beneficial intestinal bacteria supplement, if it will cause improvement of the non-alcoholic fatty liver disease (NAFLD) and or non-alcoholic steatohepatitis (NASH- an inflammation with concurrent fatty accumulation of the liver) as measured by tr...
What is the current status of trial NCT04175392?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2021-01-12. Estimated completion is 2022-03-01.
What interventions are being tested in trial NCT04175392?
The interventions under investigation include: Placebos (DRUG), Align Probiotic Supplement Capsule (DRUG).
Who is sponsoring clinical trial NCT04175392?
This trial is sponsored by Corewell Health East, which has 106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04175392's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 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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