Effect of Rifaximine on Sleep Disorders in Patients Suffering From Hepatic Encephalopathy

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-07-31

Brief Summary

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Hepatic encephalopathy is responsible for sleep disturbances and daytime sleepiness. The purpose of our study is to assess sleep quality, quantity, sleep schemes and physical activity in patients suffering from HE, before and after a 2 weeks treatment with rifaximine, which is currently given to lower blood ammoniac levels.

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Detailed Description

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Hepatic encephalopathy (HE) is a complex neuropsychiatric syndrome related to chronic/acute hepatic failure. Sleep architecture is disturbed in this syndrome, and patients complain mainly of excessive daytime sleepiness and sleep disturbances. Hypothesis to explain these symptoms is, among others, disturbed melatonin metabolism. Few studies have been conducted in order to study sleep disorders during HE, and effect of treatment is unknown. Recently, rifaximine, an oral broad spectrum antibiotic, have been proved to decrease ammoniac production in patients with HE. The purpose of our study is to assess sleep quality, quantity, sleep schemes and physical activity in patients suffering from HE, before and after a 2 weeks treatment with rifaximine.

Conditions

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Hepatic Encephalopathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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rifaximine

Group Type EXPERIMENTAL

rifaximine

Intervention Type DRUG

Interventions

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rifaximine

Intervention Type DRUG

Other Intervention Names

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Targaxan

Eligibility Criteria

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Inclusion Criteria

* \>18y hepatic encephalopathy: positive Conn score

Exclusion Criteria

* \<18y pregnancy inability to fulfil questionnaires acute infection unstable clinical condition bone or articular disease resulting in significant disability

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No