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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
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Cognitive Function based on the Animal Naming Test (ANT)
Days-alive and out-of-the-hospital
Death/transplant
+14 moreTrial 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
Lactulose
2023
Completed Phase 4
~2030
Enhanced Usual Care
2019
Completed Phase 3
~8530
Find a Location
Who is running the clinical trial?
University of MichiganLead Sponsor
1,798 Previous Clinical Trials
6,377,708 Total Patients Enrolled
7 Trials studying Liver Cirrhosis
7,143 Patients Enrolled for Liver Cirrhosis
Patient-Centered Outcomes Research InstituteOTHER
551 Previous Clinical Trials
29,997,028 Total Patients Enrolled
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: Enhanced usual care group followed by Tele-Tai Chi exercise classes
- Group 2: Treatment (Lactulose) plus enhanced usual care then recommended exercise
- Group 3: Treatment (Lactulose) group plus enhanced usual care
- Group 4: Enhanced usual care group followed by investigator recommended exercise
- Group 5: Treatment (Lactulose) plus enhanced usual care then TeleTai-Chi exercise classes
- Group 6: Enhanced usual care group
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What can be concluded regarding the safety of Lactulose in combination with additional medical care?
"The safety of the Treatment (Lactulose) group plus enhanced usual care is rated at a 3 since prior clinical data has demonstrated efficacy and multiple confirmations of safety."
Answered by AI
Are there any vacancies available for participants in this clinical trial?
"According to clinicaltrials.gov, this trial is not presently recruiting patients. Initially posted on May 1st 2023 and last modified March 20th of the same year; although no longer taking applicants, 474 other medical trials are still accepting enrollees."
Answered by AI
Who else is applying?
What state do they live in?
Michigan
What site did they apply to?
University of Michigan
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
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