Low-dose Rifaximin in the Treatment of Covert Hepatic Encephalopathy

Phase 4

Completed

• Conditions: Covert Hepatic Encephalopathy
• Interventions: Drug: Rifaximin

• Registration Number: NCT03077217
• Lead Sponsor: Shanghai Changzheng Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-30
• Study First Submitted QC: 2017-03-06
• Study First Posted: 2017-03-10
• Study Start: 2017-05-01
• Primary Completion: 2020-05-31
• Study Completion: 2020-05-31
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-28
• Last Update Posted: 2021-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the high-dose rifaximin	Rifaximin	The high-dose rifaximin group was given rifaximin 1200 mg/day for 8 weeks.
the control group	Rifaximin	The control group didn't receive rifaximin treatment
the low-dose rifaximinl group	Rifaximin	The low-dose rifaximin group was given rifaximin 800 mg/day for 8 weeks.

Primary Outcome Measures

Name	Time	Method
health-related quality of life improvement	up to 6 month	complete the questionnaire "sickness impact profile"
Percentage of patients showing covert hepatic encephalopathy reversal	up to 6 months	the percentage of patients showing covert hepatic encephalopathy reversal

Trial Locations

Locations (1)

Shanghai changzheng Hospital; 🇨🇳 Shanghai, Shanghai, China