A Trial to Improve Quality of Life in People With Cirrhosis

Phase 2

Completed

• Conditions: Cirrhosis
• Interventions: Drug: Lactulose

• Registration Number: NCT05061992
• Lead Sponsor: University of Michigan

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-20
• Study First Submitted QC: 2021-09-20
• Study First Posted: 2021-09-30
• Study Start: 2021-11-10
• Primary Completion: 2022-11-01
• Study Completion: 2022-11-01
• Results First Submitted: 2023-10-18
• Status Verified: 2023-11
• Results First Submitted QC: 2023-11-17
• Last Update Submitted: 2023-11-17
• Results First Posted: 2023-11-21
• Last Update Posted: 2023-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lactulose	Lactulose	-

Primary Outcome Measures

Name	Time	Method
Short Form-8 Health Survey (SF-8) at 28 Days	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).

Secondary Outcome Measures

Name	Time	Method
Animal Naming Test (ANT)	28 days	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.
Participants Who Fell	28 days	Yes or no question on whether participant had experienced at least 1 fall in the past 28 days.
Daily Bowel Movements	28 days	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
Change in Overall Sleep Quality	Change between baseline (day 0) and 28 days	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).
Regular Daily Activity Impairment	28 days	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)

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States