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Completed

NCT Number: NCT05061992

A Trial to Improve Quality of Life in People With Cirrhosis

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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Key information

Conditions

Cirrhosis Brain Diseases Brain Diseases, Metabolic Central Nervous System Diseases Digestive System Diseases Fibrosis Hepatic Encephalopathy Hepatic Insufficiency Hypertension, Portal Liver Diseases Liver Failure Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Other names: Kristalose

Primary outcomes

  1. Short Form-8 Health Survey (SF-8) at 28 Days

    Time frame: 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 outcomes

  1. Animal Naming Test (ANT)

    Time frame: 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.

  2. Change in Overall Sleep Quality

    Time frame: 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).

  3. Regular Daily Activity Impairment

    Time frame: 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)

  4. Participants Who Fell

    Time frame: 28 days

    Yes or no question on whether participant had experienced at least 1 fall in the past 28 days.

  5. Daily Bowel Movements

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 30, 2021
Registry last updated
Nov 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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