Phase 3
N=56
A Trial to Improve Quality of Life in People With Cirrhosis
Cirrhosis
Bottom Line
View on ClinicalTrials.gov: NCT05061992 ↗Enrolled (actual)
56
Serious AEs
3.6%
Results posted
Nov 2023
Primary outcome: Primary: Short Form-8 Health Survey (SF-8) at 28 Days — 8.1; 6.55; 70.9; 63.84 score on a scale — p=0.6
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Lactulose (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Short Form-8 Health Survey (SF-8) at 28 Days |
8.1; 6.55; 70.9; 63.84 | 0.6 |
| SECONDARY Animal Naming Test (ANT) |
3.7; -0.15; 21.2; 18.52 | 0.001 sig |
| SECONDARY Change in Overall Sleep Quality |
0.4; 0.0 | 0.05 |
| SECONDARY Regular Daily Activity Impairment |
3.0; 4.8 | 0.02 sig |
| SECONDARY Participants Who Fell |
1; 3 | 0.6 |
| SECONDARY Daily Bowel Movements |
5; 2 | 0.2 |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT05061992). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.