A Trial to Improve Quality of Life in People With Cirrhosis

NCT05061992 | Completed Phase 2 Results FDA Drug

• 1 other identifier: HUM00204056
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Cirrhosis

Keywords

Hepatic Encephalopathy; Liver Disease; Cirrhosis and portal hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Animal Naming Test (ANT)

  28 days

• Change in Overall Sleep Quality

  Change between baseline (day 0) and 28 days

• Regular Daily Activity Impairment

  28 days

• Participants Who Fell

  28 days

• Daily Bowel Movements

  28 days

Study Arms (2)

Lactulose

EXPERIMENTAL

Drug: Lactulose

No treatment

NO INTERVENTION

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

Interventions

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.

Also known as: Kristalose

Lactulose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of cirrhosis - must meet one of the following criteria:
• liver biopsy, OR
• history of cirrhosis complication: ascites, variceal bleeding, hepatic encephalopathy, OR
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Fibrosis; Hepatic Encephalopathy; Liver Diseases; Hypertension, Portal

Interventions

Lactulose

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Failure; Hepatic Insufficiency; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Results Point of Contact

• Title: Dr. Elliot Tapper
• Organization: University of Michigan

etapper@med.umich.edu

734-647-9252

Study Officials

• Elliot Tapper, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Internal Medicine

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: September 30, 2021
• Study Start: November 10, 2021
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: November 21, 2023
• Results First Posted: November 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)