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NCT Number: NCT03077217

Low-dose Rifaximin in the Treatment of Covert Hepatic Encephalopathy

Several studies have been showed that rifaximin can improve cognitive functions, driving simulator performance and health-related quality of life in patients with minimal hepatic encephalopathy. The aim of this prospective randomized open controlled study was to evaluate the efficacy and safety of rifaximin at different doses for the treatment of covert hepatic encephalopathy.

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Key information

Conditions

Covert Hepatic Encephalopathy

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Shanghai changzheng Hospital

Shanghai, Shanghai Municipality, 200003, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients agreed to sign the informed consents
  • Patients aged 18-70 years，males or females
  • Patients who were diagnosed with occult hepatic encephalopathy by PHES and Stroop tests

Exclusion criteria

  • Allergy to rifamycin/rifamutin/rifampin/rifapentine
  • Current or recent (<3 month) use of alcohol or can't stop drinking during the study period
  • Use of antibiotics within last 6 weeks
  • Use of lactulose/lactitol, probiotics, L-ornithine-L-aspart，zinc，metronidazole, neomycin, or rifaximin within last 6 weeks
  • Infection or gastrointestinal hemorrhage within last 6 weeks
  • Use of psychoactive drugs within last 6 weeks
  • Occurred overt hepatic encephalopathy within last 3 months
  • history of portosystemic shunt surgery or transjugular intrahepatic portosystemic shunt
  • Poor vision, color blindness or motor defects that interfere with the performance of psychometric tests
  • Other non-controllable neurological or psychiatric problems which may affect cognitive function such as Alzheimer's disease, Parkinson's disease or schizophrenia
  • Conformed or highly suspicious diagnosis of liver malignant tumors
  • Human immunodeficiency virus (HIV) infection
  • Uncontrolled hypertension, diabetes or other serious cardiac and pulmonary diseases
  • White blood cell count<1×10^9/L
  • Pregnancy and breastfeeding
  • Participated in other drug clinical trials within 3 months
  • The researchers thought it was not suitable for this clinical trial

Treatment and study plan

Rifaximin

Drug

The investigators use low-dose rifaximin for the treatment of patients with covert hepatic encephalopathy

Primary outcomes

  1. Percentage of patients showing covert hepatic encephalopathy reversal

    Time frame: up to 6 months

    the percentage of patients showing covert hepatic encephalopathy reversal

  2. health-related quality of life improvement

    Time frame: up to 6 month

    complete the questionnaire "sickness impact profile"

Sponsors and collaborators

Lead sponsor

Shanghai Changzheng Hospital

Other

Registry information

Official study title

Low-dose Rifaximin in the Treatment of Covert Hepatic Encephalopathy: A Randomized Open Controlled Study

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Mar 10, 2017
Registry last updated
Jul 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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