Condition category
Nutritional, Metabolic, Endocrine
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
Hepatic encephalopathy (HE) is a complication of advanced liver disease. It happens when the liver is not able to break down toxins from the bowel which then enter the blood stream and travel to the brain. It can cause the patient to become confused and lead to a reduced level of consciousness. HE often results in emergency admission to hospital and can result in reduced quality of life. The first-line treatment of HE is the laxative lactulose which increases stool frequency and reduces absorption of toxins produced by bacteria in the gut. However, in spite of this treatment, HE often worsens, leading to readmission into hospital. One potential contributing factor is that large doses of lactulose can be unpleasant for patients to take, meaning that they are less likely to take it, particularly when there appears to be no evidence of ongoing confusion. The aim of this study is to investigate the use of a home monitoring system to direct lactulose treatment in patients who have had a previous episode of HE.

Who can participate?
Patients aged 18-80 with advanced liver disease who have had a previous episode of HE

What does the study involve?
Participants take a simple cognitive (thinking) test on a daily basis and they record their stool frequency using a tablet PC. This information is used to adjust lactulose dose
where appropriate. In situations where there is evidence of increasing confusion which is not responding to treatment, a clinician intervenes.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
University of Newcastle upon Tyne (UK)

When is the study starting and how long is it expected to run for?
November 2014 to July 2015

Who is funding the study?
1. European Commission Information Society and Media Directorate General
2. National Institute for Health Research (UK)

Who is the main contact?
Dr James Orr

Trial website

Contact information



Primary contact

Dr James Orr


Contact details

University of Newcastle upon Tyne
Institute of Cellular Medicine
Claremont Road
Newcastle Upon Tyne
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number

17803, IRAS 156104

Study information

Scientific title

Home Monitoring in Encephalopathy: a randomised controlled trial



Study hypothesis

This pilot evaluation aims to investigate the use of a home monitoring system to direct lactulose therapy in patients with a previous episode of overt hepatic encephalopathy.

Ethics approval

Approved 29/09/2014, North East - Newcastle & North Tyneside 1 Research Ethics Committee, REC ref: 14/NE/1114

Study design

Randomised; Interventional; Design type: Treatment

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet


Topic: Gastroenterology, Hepatology; Subtopic: Hepatology, Gastroenterology; Disease: All Gastroenterology, All Hepatology


Electronic home monitoring: Using a tablet PC, patients will carry out a cognitive test and a health enquiry on a daily basis. Based on this treatment for hepatic encephalopathy will be optimised.
Follow Up Length: 6 month(s)

Intervention type



Drug names

Primary outcome measure

Patient acceptability; Timepoint(s): 8 weeks, 16 weeks, 24 weeks

Secondary outcome measures

1. Admission rates; Timepoint(s): throughout study
2. Completion rate; Timepoint(s): throughout trial
3. Health related quality of life; Timepoint(s): 8 weeks, 16 weeks, 24 weeks
4. Healthcare resource utilisation; Timepoint(s): 8 weeks, 16 weeks 24 weeks
5. Rate of change of therapy; Timepoint(s): throughout study

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Age 18-80 years
2. Patient has capacity and provided written informed consent for participation in the study prior to any study specific procedures
3. Cirrhosis defined either histologically on liver biopsy OR clinically by 2 of:
3.1. Imaging suggestive of cirrhosis (irregular outline and/or spleen >12cm)
3.2. Fibroscan >17.6kPa
3.3. Oesophageal or gastric varices or portal hypertensive gastropathy
3.4. Platelets <120
3.5. Ascites
3.6. Encephalopathy
4. Inpatient at Freeman Hospital, Newcastle or Royal Victoria Infirmary, Newcastle due to overt hepatic encephalopathy (OHE), treated with lactulose

Participant type


Age group




Target number of participants

Planned Sample Size: 20; UK Sample Size: 20

Participant exclusion criteria

1. Age <18 or >80
2. Unable to provide informed consent
3. Unable to understand written English
4. Malignancy (including HCC)
5. Participating in another interventional study
6. Previous participation in this study

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

University of Newcastle upon Tyne
Institute of Cellular Medicine Claremont Road
Newcastle Upon Tyne
United Kingdom

Sponsor information


Newcastle upon Tyne Hospitals NHS Foundation Trust

Sponsor details

Leazes Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle Upon Tyne
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name

European Commission Information Society and Media Directorate General

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

National Institute for Health Research

Alternative name(s)


Funding Body Type

government organisation

Funding Body Subtype

National government


United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

2015 abstract in (added 02/09/2020)

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

02/09/2020: Abstract, IRAS Project ID and ethics approval details added. 15/08/2017: Plain English summary added. No publications found, verifying study status with principal investigator.