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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05061992
Other study ID # HUM00204056
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date November 10, 2021
Est. completion date November 1, 2022

Study information

Verified date November 2023
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date November 1, 2022
Est. primary completion date November 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States University of Michigan Ann Arbor Michigan

Sponsors (1)

Lead Sponsor Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

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