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Lactulose + TeleTai-Chi for Liver Cirrhosis
Phase 3
Recruiting
Led By Elliott Tapper, MD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 and 24 weeks
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial will determine if a combination of lactulose and TeleTai-Chi can reduce the rate of falls, HE, and death in people with cirrhosis.
Who is the study for?
This trial is for people with liver cirrhosis and signs of portal hypertension, who are willing to exercise and have access to a device with Wi-Fi. They must speak English or Spanish. Excluded are those with recent severe hepatic encephalopathy, high MELD scores (unless stable on dialysis), certain cancer treatments, frequent paracentesis, living in assisted facilities, very high hemoglobin A1C levels, or doing Tai-Chi/vigorous activity already.
What is being tested?
The LiveSMART Trial tests if lactulose followed by virtual Tai-Chi can reduce falls and improve cognitive function over 24 weeks compared to other treatments in patients with cirrhosis. Participants will be randomly assigned to different treatment combinations for two stages lasting approximately 12 weeks each.
What are the potential side effects?
Lactulose may cause digestive issues like bloating and diarrhea. TeleTai-Chi is generally safe but could potentially lead to muscle soreness or strain from the exercises.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 and 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 and 24 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of patients experiencing a hierarchical composite of events over 24 weeks: injurious falls, non-injurious falls, incident Hepatic Encephalopathy, liver transplant, and death/transplant
Secondary study objectives
Cognitive Function based on the Animal Naming Test (ANT)
Days-alive and out-of-the-hospital
Death/transplant
+14 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
6Treatment groups
Experimental Treatment
Active Control
Group I: Treatment (Lactulose) plus Enhanced Usual Care then recommended exerciseExperimental Treatment3 Interventions
This is considered stage 2 for 12 weeks (for re-randomized participants)
Group II: Treatment (Lactulose) plus Enhanced Usual Care then TeleTai-Chi exercise classesExperimental Treatment3 Interventions
This is considered stage 2 for 12 weeks (for re-randomized participants)
Group III: Treatment (Lactulose) group plus Enhanced Usual CareExperimental Treatment2 Interventions
Participants will be in stage 1 for approximately 12 weeks and then be re-randomized for stage 2.
Group IV: Enhanced Usual Care group followed by Tele-Tai Chi exercise classesExperimental Treatment2 Interventions
This is considered stage 2 for 12 weeks (for re-randomized participants)
Group V: Enhanced Usual Care group followed by investigator recommended exerciseActive Control2 Interventions
This is considered stage 2 for 12 weeks (for re-randomized participants).
Group VI: Enhanced Usual Care groupActive Control1 Intervention
Participants will be in stage 1 for approximately 12 weeks and then be re-randomized for stage 2.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enhanced Usual Care
2019
Completed Phase 3
~8420
Lactulose
2023
Completed Phase 4
~2030
Find a Location
Who is running the clinical trial?
University of MichiganLead Sponsor
1,854 Previous Clinical Trials
6,433,131 Total Patients Enrolled
11 Trials studying Liver Cirrhosis
7,579 Patients Enrolled for Liver Cirrhosis
Patient-Centered Outcomes Research InstituteOTHER
574 Previous Clinical Trials
27,078,529 Total Patients Enrolled
1 Trials studying Liver Cirrhosis
30,300 Patients Enrolled for Liver Cirrhosis
Elliott Tapper, MDPrincipal InvestigatorUniversity of Michigan
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently undergoing physical therapy.I have taken lactulose for reasons other than brain liver issues for over 28 days in the last 6 months.I have been diagnosed with cirrhosis through tests or imaging.My liver cancer is advanced (beyond stage C).I am currently on specific medications.My liver disease is severe, but my kidneys are stable with low bilirubin.I speak English or Spanish.I have had more than 3 fluid removal procedures from my abdomen each month for the last 2 months.I have had severe liver-related brain issues needing long-term treatment in the last 6 months.I have had cancer spread or leukemia in the last 3 years.I have taken Rifaximin for more than 28 days in the last 6 months.I have had fluid build-up in my abdomen recently or within the last 2 years.I am willing to join an exercise program.I am willing to join an exercise program.You have access to Wi-Fi in your domicile.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (Lactulose) plus Enhanced Usual Care then TeleTai-Chi exercise classes
- Group 2: Treatment (Lactulose) plus Enhanced Usual Care then recommended exercise
- Group 3: Enhanced Usual Care group followed by investigator recommended exercise
- Group 4: Enhanced Usual Care group
- Group 5: Enhanced Usual Care group followed by Tele-Tai Chi exercise classes
- Group 6: Treatment (Lactulose) group plus Enhanced Usual Care
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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