Trials / Completed
CompletedNCT05061992
A Trial to Improve Quality of Life in People With Cirrhosis
A Trial to Improve Quality of Life in People With Cirrhosis - the Michigan Kristalose Trial
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 56 (actual)
- Sponsor
- University of Michigan · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lactulose | Participants will take 20 grams (dissolved in 4ounces of water/beverage) doses of lactulose twice daily (upon awakening and then 4 hours later) for 28 days. In addition, outcome measurements will be completed at baseline and day 28. |
Timeline
- Start date
- 2021-11-10
- Primary completion
- 2022-11-01
- Completion
- 2022-11-01
- First posted
- 2021-09-30
- Last updated
- 2023-11-21
- Results posted
- 2023-11-21
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05061992. Inclusion in this directory is not an endorsement.