CirrhosisPhase 2/3NCT05061992

A Trial to Improve Quality of Life in People With Cirrhosis

A Phase 2/3 study testing Lactulose in people with Cirrhosis, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cirrhosis
What is being tested?: Lactulose
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 56 participants
Where: 1 siteUnited States
Study dates: 10 Nov 2021to 1 Nov 2022
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of cirrhosis - must meet one of the following criteria:
liver biopsy, OR
history of cirrhosis complication: ascites, variceal bleeding, hepatic encephalopathy, OR
2 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

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Michigan
Ann Arbor, Michigan, 48109

Other trials in United States

About this study

Official title: A Trial to Improve Quality of Life in People With Cirrhosis - the Michigan Kristalose Trial

Conditions: Cirrhosis
Being tested: Lactulose
Keywords: Hepatic Encephalopathy, Liver Disease, Cirrhosis and portal hypertension
Medical subject headings: Fibrosis, Hepatic Encephalopathy, Liver Diseases, Hypertension, Portal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LactuloseDrug
Also called Kristalose
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.

Study groups in NCT05061992
Study group	Role	What they receive
Lactulose	Experimental	Not described Receives: Drug: Lactulose
No treatment	No intervention	Subjects will complete baseline and outcome assessments at 28 days and no intervention or placebo will be prescribed.

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 28 days

Secondary outcomes (5)

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.
Measured: 28 days
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).
Measured: Change between baseline (day 0) and 28 days
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)
Measured: 28 days
Participants Who Fell
Yes or no question on whether participant had experienced at least 1 fall in the past 28 days.
Measured: 28 days
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
Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Nov 20211 Nov 2022

First posted30 Sep 2021
Study start10 Nov 2021
Primary completion1 Nov 2022
Study completion1 Nov 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for CirrhosisStudies of the same condition, open and under way.
More trials run by University of MichiganThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05061992
Sponsor's protocol ID: HUM00204056
Status last verified: Nov 2023
First submitted: 20 Sep 2021
Last updated: 21 Nov 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
Recruiting
CirrhosisRx CDS System
Cirrhosis, Decision Support Systems, Clinical
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD

All Cirrhosis trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Trial to Improve Quality of Life in People With Cirrhosis - the Michigan Kristalose Trial
ClinicalTrials.gov ID: NCT05061992
Acronym / sponsor ID: HUM00204056
Conditions: Cirrhosis
Keywords: Hepatic Encephalopathy, Liver Disease, Cirrhosis and portal hypertension
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Study start: 10 Nov 2021 (actual)
Primary completion: 1 Nov 2022 (actual)
Study completion: 1 Nov 2022 (actual)
First posted: 30 Sep 2021 (actual)
Results: Posted 21 Nov 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Diagnosis of cirrhosis - must meet one of the following criteria:

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LactuloseAlso: KristaloseParticipants 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.	Drug	Lactulose

Primary outcome

Short Form-8 Health Survey (SF-8) at 28 Days
Time frame: 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).

5 secondary outcomes

Animal Naming Test (ANT)
Time frame: 28 days
Change in Overall Sleep Quality
Time frame: Change between baseline (day 0) and 28 days
Regular Daily Activity Impairment
Time frame: 28 days
Participants Who Fell
Time frame: 28 days
Daily Bowel Movements
Time frame: 28 days

Results and safety

Results posted to the registry on 21 Nov 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lactulose	28	25
No Treatment	28	27

Primary outcome: Short Form-8 Health Survey (SF-8) at 28 Days

Time frame: 28 days. Mean (95% Confidence Interval). Unit: score on a scale

Measure	Lactulose n = 25	No Treatment n = 27
Change in SF-8 from Baseline	8.1 (3.7 to 12.4)	6.55 (2.3 to 10.8)
End of Trial SF-8	70.9 (63.9 to 77.9)	63.84 (57.1 to 70.6)

Lactulose vs No Treatment: p = 0.6, ANCOVA
Lactulose vs No Treatment: p = 0.2, ANCOVA

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 28 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lactulose	1 of 28 (3.6%)	1 of 28 (3.6%)	0 of 28
No Treatment	1 of 28 (3.6%)	3 of 28 (10.7%)	0 of 28

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Cirrhosis

RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
Recruiting
CirrhosisRx CDS System
Cirrhosis, Decision Support Systems, Clinical
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Elliot Tapper, MD principal investigator

University of Michigan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Lactulose in people with Cirrhosis, run by University of Michigan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Short Form-8 Health Survey (SF-8) at 28 Days (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05061992.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023.