430 Participants Needed

Lactulose + TeleTai-Chi for Liver Cirrhosis

Recruiting at 2 trial locations
SN
Overseen BySamantha Nikirk
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This multicenter trial is being conducted to determine if sequential lactulose and Tele (virtual) Tai-Chi reduces the rate of injurious fall, non-injurious falls, incident overt Hepatic Encephalopathy (HE), and death or liver transplant over 24 weeks. Participants that are enrolled will be randomized to stage one of this project for approximately 12 weeks. After completing stage one, participants will be re-randomized to stage 2 of the project that will last approximately 12 more weeks. The study hypothesizes that sequential lactulose/TeleTai-Chi will reduce falls, incident overt HE, death and physical frailty and will improve cognitive function, and Health Related Quality of Life (HRQOL) over 24 weeks compared to other treatment combinations.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop your current medications. However, if you are currently taking Sorafenib, Atezolizumab/Bevacizumab, Regorafinib, or Cabozatinib, you cannot participate in the trial.

What data supports the effectiveness of the treatment Lactulose + TeleTai-Chi for Liver Cirrhosis?

Research shows that lactulose, a component of the treatment, is effective in reducing blood ammonia levels and improving mental function in patients with liver cirrhosis, which can help manage hepatic encephalopathy (a brain disorder caused by liver disease).12345

What makes the Lactulose + TeleTai-Chi treatment unique for liver cirrhosis?

This treatment is unique because it combines lactulose, a sugar that helps reduce blood ammonia levels, with TeleTai-Chi, a virtual exercise program that may improve overall well-being and immune function, offering a holistic approach to managing liver cirrhosis.12345

Research Team

ET

Elliott Tapper, MD

Principal Investigator

University of Michigan

MS

Marina Serper, MD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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.

Inclusion Criteria

Evidence of portal hypertension meeting specified criteria
I have been diagnosed with cirrhosis through tests or imaging.
Access to Wireless Fidelity (Wi-Fi) at home
See 2 more

Exclusion Criteria

Severe cognitive, vision, or hearing impairment (without use of corrective lenses or hearing assist devices) or psychiatric illness precluding study participation
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.
See 12 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Stage 1 Treatment

Participants receive lactulose plus enhanced usual care for approximately 12 weeks

12 weeks

Stage 2 Treatment

Participants are re-randomized to receive either TeleTai-Chi or recommended exercise for an additional 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Enhanced Usual Care
  • Investigator recommended exercise
  • Lactulose
  • TeleTai-Chi (virtual)
Trial Overview 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.
Participant Groups
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.

Lactulose is already approved in United States, European Union, Canada for the following indications:

๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Lactulose for:
  • Hepatic encephalopathy
  • Constipation
๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as Lactulose for:
  • Hepatic encephalopathy
  • Constipation
๐Ÿ‡จ๐Ÿ‡ฆ
Approved in Canada as Lactulose for:
  • Hepatic encephalopathy
  • Constipation

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials
1,891
Recruited
6,458,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials
592
Recruited
27,110,000+

Findings from Research

In a study involving 40 patients with liver cirrhosis and hepatic encephalopathy, both crystalline pure lactulose (Laevolac Cristalli) and lactitol were effective in maintaining treatment for the condition.
Crystalline lactulose had a significantly lower incidence of side effects compared to previous formulations, making it better tolerated and more accepted by patients while maintaining similar efficacy.
[A clinical comparative study of crystalline pure lactulose and powder pure lactitol in portasystemic encephalopathy of cirrhotic patients].Grandi, M., Sacchetti, C., Pederzoli, S., et al.[2015]
In a study involving 20 cirrhotic patients, treatment with crystalline lactulose for 30 days significantly reduced blood ammonia levels compared to a control group, indicating its efficacy in managing liver function complications.
Lactulose treatment also appeared to enhance certain immune responses, such as increased CD16 lymphocyte levels and antibacterial activity, suggesting it may help activate the immune system in patients with liver cirrhosis.
Crystalline lactulose in the therapy of hepatic cirrhosis. Evaluation of clinical and immunological parameters. Preliminary results.Vendemiale, G., Palasciano, G., Cirelli, F., et al.[2013]
Non-absorbable disaccharides, such as lactulose and lactitol, significantly reduce mortality and improve hepatic encephalopathy symptoms in patients with cirrhosis, based on a systematic review of 38 randomized clinical trials involving 1828 participants.
The use of non-absorbable disaccharides also appears to lower the risk of serious adverse events related to liver disease, indicating their potential as a safe and effective treatment option for hepatic encephalopathy.
Non-absorbable disaccharides versus placebo/no intervention and lactulose versus lactitol for the prevention and treatment of hepatic encephalopathy in people with cirrhosis.Gluud, LL., Vilstrup, H., Morgan, MY.[2022]

References

[A clinical comparative study of crystalline pure lactulose and powder pure lactitol in portasystemic encephalopathy of cirrhotic patients]. [2015]
Crystalline lactulose in the therapy of hepatic cirrhosis. Evaluation of clinical and immunological parameters. Preliminary results. [2013]
Non-absorbable disaccharides versus placebo/no intervention and lactulose versus lactitol for the prevention and treatment of hepatic encephalopathy in people with cirrhosis. [2022]
Lactulose improves psychometric testing in cirrhotic patients with subclinical encephalopathy. [2019]
Non-absorbable disaccharides versus placebo/no intervention and lactulose versus lactitol for the prevention and treatment of hepatic encephalopathy in people with cirrhosis. [2020]
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