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A Trial to Improve Quality of Life in People With Cirrhosis

Sponsor
University of Michigan (Other)
Overall Status
Recruiting
CT.gov ID
NCT05061992
Collaborator
(none)
75
Enrollment
1
Location
2
Arms
22.7
Anticipated Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Trial to Improve Quality of Life in People With Cirrhosis - the Michigan Kristalose Trial
Actual Study Start Date :
Nov 10, 2021
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lactulose

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.
Other Names:
  • Kristalose

    		•
    No Intervention: No treatment

    Subjects will complete baseline and outcome assessments at 28 days and no intervention or placebo will be prescribed.

    Outcome Measures

    Primary Outcome Measures

    1. 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. It contains psychometrically based physical and mental health summary measures. The eight domains include general health, physical functioning, role physical, bodily pain, vitality, social functioning, mental health and role emotional (0 no quality of life-100 highest quality of living).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

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

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

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

    7. 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Michigan Ann Arbor Michigan United States 48109

    Sponsors and Collaborators

    • University of Michigan

    Investigators

    • Principal Investigator: Elliot Tapper, MD, University of Michigan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Elliot B. Tapper, Assistant Professor of Internal Medicine, University of Michigan
    ClinicalTrials.gov Identifier:
    NCT05061992
    Other Study ID Numbers:
    • HUM00204056
    First Posted:
    Sep 30, 2021
    Last Update Posted:
    Nov 15, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Elliot B. Tapper, Assistant Professor of Internal Medicine, University of Michigan
    Hepatic Encephalopathy
    Liver Disease
    Cirrhosis and portal hypertension
    Additional relevant MeSH terms:
    Liver Cirrhosis
    Fibrosis
    Lactulose

    Study Results

    No Results Posted as of Nov 15, 2021