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A Trial to Improve Quality of Life in People With Cirrhosis

Primary Purpose

Cirrhosis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lactulose
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cirrhosis focused on measuring Hepatic Encephalopathy, Liver Disease, Cirrhosis and portal hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Lactulose

No treatment

Arm Description

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

Outcomes

Primary Outcome Measures

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. 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).

Secondary Outcome Measures

Full Information

First Posted
September 20, 2021
Last Updated
November 2, 2022
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT05061992
Brief Title
A Trial to Improve Quality of Life in People With Cirrhosis
Official Title
A Trial to Improve Quality of Life in People With Cirrhosis - the Michigan Kristalose Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
November 10, 2021 (Actual)
Primary Completion Date
November 1, 2022 (Actual)
Study Completion Date
November 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis
Keywords
Hepatic Encephalopathy, Liver Disease, Cirrhosis and portal hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lactulose
Arm Type
Experimental
Arm Title
No treatment
Arm Type
No Intervention
Arm Description
Subjects will complete baseline and outcome assessments at 28 days and no intervention or placebo will be prescribed.
Intervention Type
Drug
Intervention Name(s)
Lactulose
Other Intervention Name(s)
Kristalose
Intervention Description
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.
Primary Outcome Measure Information:
Title
Short Form-8 Health Survey (SF-8) at 28 days
Description
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).
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elliot Tapper, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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A Trial to Improve Quality of Life in People With Cirrhosis

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