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Lactulose for Liver Cirrhosis

Phase 2 & 3
Waitlist Available
Led By Elliot 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 28 days
Awards & highlights

Study Summary

This trial is evaluating whether Kristalose can improve quality of life, sleep and cognitive function in patients with cirrhosis who have not been diagnosed with HE, but report reduced quality of life.

Eligible Conditions
  • Liver Cirrhosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Short Form-8 Health Survey (SF-8) at 28 Days
Secondary outcome measures
Animal Naming Test (ANT)
Change in Overall Sleep Quality
Daily Bowel Movements
+2 more

Side effects data

From 2014 Phase 4 trial • 222 Patients • NCT01842581
19%
Hepatic encephalopathy
17%
Oedema peripheral
16%
Constipation
14%
Nausea
14%
Fatigue
12%
Insomnia
11%
Urinary tract infection
10%
Pruritus generalised
8%
Muscle spasms
7%
Abdominal pain
7%
Decreased appetite
6%
Ascites
6%
Dyspnoea
6%
Headache
5%
Cough
5%
Renal failure acute
5%
Vomiting
5%
Asthenia
5%
Anaemia
5%
Anxiety
4%
Jaundice
4%
Diarrhoea
3%
Abdominal distension
3%
Cellulitis
3%
Depression
2%
Bronchitis
2%
Peritonitis bacterial
2%
Hyperkalaemia
2%
Liver transplant
1%
Haematemesis
1%
Hyperglycaemia
1%
Fluid overload
1%
Non-cardiac chest pain
1%
Gastrointestinal haemorrhage
1%
Acute respiratory failure
1%
Herpes zoster
1%
Cerebrovascular accident
1%
Thrombocytopenia
1%
Pneumococcal bacteraemia
1%
Pneumonia
1%
Sepsis
1%
Septic shock
1%
Craniocerebral injury
1%
Hepatic failure
1%
Hepatitis
1%
Hepatorenal syndrome
1%
Toxic encephalopathy
1%
Subarachnoid haemorrhage
1%
Anxiety disorder
1%
Suicidal ideation
1%
Calculus ureteric
1%
Oliguria
1%
Renal failure
1%
Pleural effusion
1%
Flatulence
1%
Cardiac failure congestive
1%
Haematochezia
1%
Upper gastrointestinal haemorrhage
1%
Chest pain
1%
Systemic inflammatory response syndrome
1%
Chronic hepatic failure
1%
Subdural haematoma
1%
Dehydration
1%
Alcoholic seizure
1%
Hypovolaemic shock
100%
80%
60%
40%
20%
0%
Study treatment Arm
Rifaximin 550 mg BID
Rifaximin 550 mg BID + Lactulose

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: LactuloseExperimental Treatment1 Intervention
Group II: No treatmentActive Control1 Intervention
Subjects will complete baseline and outcome assessments at 28 days and no intervention or placebo will be prescribed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lactulose
2023
Completed Phase 4
~2030

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,796 Previous Clinical Trials
6,377,897 Total Patients Enrolled
7 Trials studying Liver Cirrhosis
7,517 Patients Enrolled for Liver Cirrhosis
Elliot Tapper, MDPrincipal InvestigatorUniversity of Michigan
4 Previous Clinical Trials
285 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Iowa
How old are they?
18 - 65
What site did they apply to?
University of Michigan
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Most responsive sites:
  1. University of Michigan: < 24 hours
Typically responds via
Phone Call
Average response time
  • < 1 Day
Recent research and studies
clinicaltrials.govStudy
A Trial to Improve Quality of Life in People With Cirrhosis
Elliot B. Tapper 2021. "A Trial to Improve Quality of Life in People With Cirrhosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05061992.
~16 spots leftby Apr 2025
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