At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 56 enrolled
Drug / intervention
Lactulosedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Trial to Improve Quality of Life in People With Cirrhosis - the Michigan Kristalose Trial
In Brief
A Phase 3 clinical trial evaluating Lactulose for Cirrhosis. Completed, enrolled 56 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCirrhosis
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20222023202420252026
First PostedSep 2021
Enrollment StartNov 2021
Primary CompletionNov 2022
TodayJul 2026
First PostedSep 30, 2021
Enrollment StartNov 10, 2021
Primary CompletionNov 1, 2022
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 4.8 years ago
Interventions
Lactulosedrug
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.