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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactulose | Experimental |
| |
| No treatment | No Intervention | Subjects will complete baseline and outcome assessments at 28 days and no intervention or placebo will be prescribed. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactulose | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 28 days |
| Change in Overall Sleep Quality |
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Inclusion Criteria:
Diagnosis of cirrhosis - must meet one of the following criteria:
liver biopsy, OR
history of cirrhosis complication: ascites, variceal bleeding, hepatic encephalopathy, OR
2 of the following 4 criteria:
Ultrasound, Computed tomography (CT) or Magnetic resonance imaging (MRI) findings of cirrhosis (cirrhotic appearing liver, splenomegaly, varices, ascites)
Fibroscan liver stiffness score >13 Kilopascal (kPa)
Laboratory testing: aspartate aminotransferase (AST)/platelet ratio index (APRI) >2.0
CT, MRI or Esophagogastroduodenoscopy (EGD) showing presence of esophageal varices
Exclusion Criteria:
Non-English speaking
Pregnancy (self-reported)
Unable or unwilling to provide consent
History of liver transplant
Disorientation at the time of enrollment, Dementia, or Treated Memory Disorder
History of prior lactulose use or HE within 6 months
Metastatic solid malignancy or blood malignancy
Hemoglobin A1C > 12 (within past year)
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| Name | Affiliation | Role |
|---|---|---|
| Elliot Tapper, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lactulose | 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. |
| FG001 | No Treatment | Subjects will complete baseline and outcome assessments at 28 days and no intervention or placebo will be prescribed. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lactulose | 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. |
| BG001 | No Treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | 95% Confidence Interval | score on a scale | 28 days |
|
28 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lactulose | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Complications from Liver Disease | Hepatobiliary disorders | Systematic Assessment | Hospitalizations occurred for participants because of complications with pre-existing liver disease. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Musculoskeletal and connective tissue disorders | Systematic Assessment | Non-injurious fall |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Elliot Tapper | University of Michigan | 734-647-9252 | etapper@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 1, 2021 | Oct 13, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D006501 | Hepatic Encephalopathy |
| D008107 | Liver Diseases |
| D006975 | Hypertension, Portal |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
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| ID | Term |
|---|---|
| D007792 | Lactulose |
| ID | Term |
|---|---|
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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|
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).
| 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) | 28 days |
| Participants Who Fell | Yes or no question on whether participant had experienced at least 1 fall in the past 28 days. | 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 | 28 days |
| Diarrhea Prior to Starting Therapy |
|
| Withdrawal by Subject |
|
Subjects will complete baseline and outcome assessments at 28 days and no intervention or placebo will be prescribed. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Short Form-8 Health Survey (SF-8) | 0 (lowest quality of living) to 100 (highest quality of living) | Mean | Standard Deviation | score on a scale |
|
| Animal Naming Test | Number of unique animals named within 1 minute by the participant. | Mean | Standard Deviation | Count of Animals Named |
|
| 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). | Mean | Standard Deviation | Score on a Scale |
|
| Activity Impairment | Single survey question where participants responded on a Likert scale of 0 (no impairment) to 10 (complete impairment) | Mean | Standard Deviation | Score on a Scale |
|
| Participants Who Fell in Past 90 Days | Yes or no question on whether participant had experienced at least 1 fall in the past 90 days. | Count of Participants | Participants |
|
| OG001 |
| No Treatment |
Subjects will complete baseline and outcome assessments at 28 days and no intervention or placebo will be prescribed. |
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | Count of Animals Named | 28 days |
|
|
|
|
| Secondary | 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). | Posted | Median | Inter-Quartile Range | score on a scale | Change between baseline (day 0) and 28 days |
|
|
|
|
| Secondary | 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) | Posted | Mean | 95% Confidence Interval | score on a scale | 28 days |
|
|
|
|
| Secondary | Participants Who Fell | Yes or no question on whether participant had experienced at least 1 fall in the past 28 days. | Posted | Count of Participants | Participants | 28 days |
|
|
|
|
| Secondary | 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 | Posted | Number | % of participant-days with >5 bowels | 28 days |
|
|
|
|
| 0 |
| 28 |
| 1 |
| 28 |
| 1 |
| 28 |
| EG001 | No Treatment | Subjects will complete baseline and outcome assessments at 28 days and no intervention or placebo will be prescribed. | 0 | 28 | 1 | 28 | 3 | 28 |
|
|
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| D004066 | Digestive System Diseases |
| D001928 | Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D000073893 |
| Sugars |
| 0.09 |
| Superiority |