A Phase 2/3 interventional study of Lactulose in Cirrhosis, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-21.
Sponsored by University of Michigan · Phase 2/3, Interventional, and Treatment
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.
1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.
This study's enrollment of 56 is below the median of 72 across 995 interventional studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Diagnosis of cirrhosis - must meet one of the following criteria:
2 of the following 4 criteria:
Exclusion Criteria:
Drug: Lactulose
Subjects will complete baseline and outcome assessments at 28 days and no intervention or placebo will be prescribed.
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.
Also known as: Kristalose
Short Form-8 Health Survey (SF-8) at 28 Days
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).
Time frame: 28 days
Animal Naming Test (ANT)
Number of unique animals named within 1 minute by the participant. Values below show the change from baseline and the results from the test taken 28 days later.
Time frame: 28 days
Change in Overall Sleep Quality
Overall sleep quality was measured on a 5-point Likert scale, with a range of 1 (very bad sleep quality) to 5 (very good sleep quality).
Time frame: Change between baseline (day 0) and 28 days
Regular Daily Activity Impairment
Single-question survey given to participants at baseline and again 28 days later. Participants ranked their daily activity impairment on a Likert scale of 0 (no impairment) to 10 (complete impairment)
Time frame: 28 days
Participants Who Fell
Yes or no question on whether participant had experienced at least 1 fall in the past 28 days.
Time frame: 28 days
Daily Bowel Movements
Results show the percentage of days in a 28-day span in which participants experienced more than 5 daily bowel movements. All participants analyzed in each arm were included in calculating the results using the following formula: (days with \>5 bowel movements) / (patient-days in study) The results are presented as a single number because they are a point estimate of a population level proportion
Time frame: 28 days
| Milestone | Lactulose | No Treatment |
|---|---|---|
| Started | 28 | 28 |
| Completed | 25 | 27 |
| Not completed | 3 | 1 |
| Withdrew: Excess bowel movements | 1 | 0 |
| Withdrew: Complications of medical care | 1 | 0 |
| Withdrew: Diarrhea prior to starting therapy | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 |
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).
| score on a scale | Lactulose | No Treatment |
|---|---|---|
| Change in SF-8 from Baseline | 8.1 (3.7 to 12.4) | 6.55 (2.3 to 10.8) |
| End of Trial SF-8 | 70.9 (63.9 to 77.9) | 63.84 (57.1 to 70.6) |
Number of unique animals named within 1 minute by the participant. Values below show the change from baseline and the results from the test taken 28 days later.
| Count of Animals Named | Lactulose | No Treatment |
|---|---|---|
| Change in ANT | 3.7 (2.1 to 5.4) | -0.15 (-1.7 to 1.4) |
| End of trial ANT | 21.2 (18.9 to 23.6) | 18.52 (16.3 to 20.8) |
Overall sleep quality was measured on a 5-point Likert scale, with a range of 1 (very bad sleep quality) to 5 (very good sleep quality).
| score on a scale | Lactulose | No Treatment |
|---|---|---|
| Change in Overall Sleep Quality | 0.4 (0.1 to 0.7) | 0.0 (-0.3 to 0.3) |
Single-question survey given to participants at baseline and again 28 days later. Participants ranked their daily activity impairment on a Likert scale of 0 (no impairment) to 10 (complete impairment)
| score on a scale | Lactulose | No Treatment |
|---|---|---|
| Regular Daily Activity Impairment | 3.0 (1.9 to 4.0) | 4.8 (3.8 to 5.8) |
Yes or no question on whether participant had experienced at least 1 fall in the past 28 days.
| Participants | Lactulose | No Treatment |
|---|---|---|
| Participants Who Fell | 1 | 3 |
Results show the percentage of days in a 28-day span in which participants experienced more than 5 daily bowel movements. All participants analyzed in each arm were included in calculating the results using the following formula: (days with \>5 bowel movements) / (patient-days in study) The results are presented as a single number because they are a point estimate of a population level proportion
| % of participant-days with >5 bowels | Lactulose | No Treatment |
|---|---|---|
| Daily Bowel Movements | 5 | 2 |
Collected over 28 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lactulose | 0/28 (0%) | 1/28 (3.6%) | 1/28 (3.6%) |
| No Treatment | 0/28 (0%) | 1/28 (3.6%) | 3/28 (10.7%) |
| Event | Lactulose | No Treatment |
|---|---|---|
| Complications from Liver DiseaseHepatobiliary disorders | 1/28 | 1/28 |
| Event | Lactulose | No Treatment |
|---|---|---|
| FallMusculoskeletal and connective tissue disorders | 1/28 | 3/28 |
| Age, Continuous(years) | Lactulose | No Treatment | Total |
|---|---|---|---|
| Mean | 58.1 ± 11.9 | 61.8 ± 11.3 | 60.0 ± 11.5 |
| Sex: Female, Male(Participants) | Lactulose | No Treatment | Total |
|---|---|---|---|
| Female | 15 | 15 | 30 |
| Male | 13 | 13 | 26 |
| Ethnicity (NIH/OMB)(Participants) | Lactulose | No Treatment | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 28 | 28 | 56 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Lactulose | No Treatment | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 2 |
| White | 27 | 26 | 53 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Lactulose | No Treatment | Total |
|---|---|---|---|
| United States | 28 | 28 | 56 |
| Short Form-8 Health Survey (SF-8)(score on a scale) | Lactulose | No Treatment | Total |
|---|---|---|---|
| Mean | 57.2 ± 18.3 | 61.1 ± 17.0 | 59.2 ± 17.7 |
| Animal Naming Test(Count of Animals Named) | Lactulose | No Treatment | Total |
|---|---|---|---|
| Mean | 17.9 ± 5.3 | 18.3 ± 6.5 | 18.1 ± 5.8 |
| Sleep Quality(Score on a Scale) | Lactulose | No Treatment | Total |
|---|---|---|---|
| Mean | 2.5 ± 0.8 | 2.5 ± 0.8 | 2.5 ± 0.8 |
2 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
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University of Michigan