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

C

Centre Hospitalier Universitaire Saint Pierre

Status

Completed

Conditions

Hepatic Encephalopathy

Treatments

Drug: rifaximine

Study type

Interventional

Funder types

Other

Identifiers

NCT02163837
AK/14-02-14/4343

Details and patient eligibility

About

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.

Full description

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.

Enrollment

15 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

15 participants in 1 patient group

rifaximine
Experimental group
Treatment:
Drug: rifaximine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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