Description of Lactulose Administration by Balloon Rectal Tube in Severe Hepatic Encephalopathy


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Acute liver failure in cirrhotic patients is associated with a one-month mortality of 48%. Encephalopathy, largely related to hyperammonemia, is a frequent complication of liver failure and is a poor prognostic marker. Lactulose decreases ammonia by acidification of the colon, replacement of urease-producing bacteria and creation of a laxative effect. Thus, the administration of lactulose in patients with severe hepatic encephalopathy reduces mortality by more than 40%.

In intensive care patients, lactulose is often administered rectally. The use of simple rectal tubes is associated with frequent leakage of lactulose as well as faecal discharge and therefore risks of infection and skin lesions. Balloon rectal tubes with a drug delivery valve have recently been developed and used in this indication. The aim of this study is therefore to describe the use of these balloon rectal tubes to administer Lactulose in severe hepatic encephalopathy.

This suggests that ammonia reduction in these patients may prolong survival time.

No studies have described the administration of Lactulose via the rectal route with a balloon tube. The descriptive methodology is therefore appropriate. This is a preliminary study allowing data collection to establish the methodology for a subsequent clinical trial.

Targeted Conditions

Study Overview

Start Date
June 7, 2022
Completion Date
December 31, 2024
Date Posted
February 8, 2024
Accepts Healthy Volunteers?


Full Address
Grenoble 38000, France


Study Population
patients with severe hepatic encephalopathy hospitalised in intensive care
Minimum Age (years)
Eligibility Criteria
Inclusion Criteria:

> 18 years
Patients treated with Lactulose with balloon rectal probe

Exclusion Criteria:

Patient(s) objecting to the use of their data for research purposes
Rectal probe contraindication: damage to the rectal mucosa, rectal surgery, severe haemorrhoids, rectal stenosis, rectal tumour,
Lactulose contraindication (person unable to absorb galactose)
Patients deprived of liberty, under guardianship or curators
Pregnant women
Patient not affiliated to a social security scheme

Study Contact Info

Study Contact Name
Pr BOUZAT; Angelina Pollet
Study Contact Phone

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FDA Regulated Drug?
FDA Regulated Device?
NCTid (if applicable)