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NCT05061992 · ClinicalTrials.gov registry record · Phase 2
A Trial to Improve Quality of Life in People With Cirrhosis
A Phase 2 study, sponsored by University of Michigan.
- Completed
- Registry status
- Phase 2
- Development phase
- 56
- Enrollment target
NCT05061992: Completed Phase 2 study, sponsored by University of Michigan.
NCT05061992 is a Phase 2 study that has completed, run by University of Michigan. The registered enrollment target is 56 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05061992, a Phase 2 study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 56 participants
- Enrollment target
Study Summary
This trial is being completed to evaluate whether a crystallized form of lactulose (Kristalose) will improve quality of life, sleep and cognitive function in patients with cirrhosis that have not been diagnosed with Hepatic Encephalopathy (HE), but report reduced quality of life.
Primary Outcome
The SF-8 is an abbreviated version of an original 36-item health survey (SF-36). It is a generic, multipurpose, quality of life instrument, containing psychometrically based physical and mental health summary measures. The eight domains are general health, physical functioning, role physical, bodily pain, vitality, social functioning, mental health, and role emotional. Scores from the domains are combined and range from 0 (lowest quality of living) to 100 (highest quality of living).
Interventions
- DRUG Lactulose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2021-11-10 |
| Est. Completion | 2022-11-01 |
| Phase | Phase 2 |
What the finished NCT05061992 record still lists
NCT05061992 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 1 intervention - of which Lactulose is the first listed.
NCT05061992 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05061992 about?
NCT05061992 is a clinical study titled "A Trial to Improve Quality of Life in People With Cirrhosis". This trial is being completed to evaluate whether a crystallized form of lactulose (Kristalose) will improve quality of life, sleep and cognitive function in patients with cirrhosis that have not been diagnosed with Hepatic Encephalopathy (HE), but report reduced quality of life.
What is the current status of trial NCT05061992?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 56 participants. The study started on 2021-11-10. Estimated completion is 2022-11-01.
What interventions are being tested in trial NCT05061992?
The interventions under investigation include: Lactulose (DRUG).
Who is sponsoring clinical trial NCT05061992?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05061992's enrollment target sits among peer trials
56 1146th of 2000 higher than 848 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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