A Trial to Improve Quality of Life in People With Cirrhosis

Cirrhosis Clinical Trial

Official title:

A Trial to Improve Quality of Life in People With Cirrhosis - the Michigan Kristalose Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05061992
• Other study ID #: HUM00204056
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: November 10, 2021
• Est. completion date: November 1, 2022

Study information

• Verified date: November 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of cirrhosis - must meet one of the following criteria:

1. liver biopsy, OR

2. history of cirrhosis complication: ascites, variceal bleeding, hepatic encephalopathy, OR

3. 2 of the following 4 criteria:

1. Ultrasound, Computed tomography (CT) or Magnetic resonance imaging (MRI) findings of cirrhosis (cirrhotic appearing liver, splenomegaly, varices, ascites)

2. Fibroscan liver stiffness score >13 Kilopascal (kPa)

3. Laboratory testing: aspartate aminotransferase (AST)/platelet ratio index (APRI) >2.0

4. 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)

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis
• Liver Cirrhosis

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	28 days
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.	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).	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)	28 days
Secondary	Participants Who Fell	Yes or no question on whether participant had experienced at least 1 fall in the past 28 days.	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	28 days