Low-dose Rifaximin in the Treatment of Covert Hepatic Encephalopathy

Covert Hepatic Encephalopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03077217
• Other study ID #: CZH0010
• Status: Completed
• Phase: Phase 4
• Start date: May 1, 2017
• Est. completion date: May 31, 2020

Study information

• Verified date: June 2021
• Source: Shanghai Changzheng Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Covert Hepatic Encephalopathy
• Hepatic Encephalopathy

Intervention

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

Locations

Country	Name	City	State
China	Shanghai changzheng Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Changzheng Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients showing covert hepatic encephalopathy reversal	the percentage of patients showing covert hepatic encephalopathy reversal	up to 6 months
Primary	health-related quality of life improvement	complete the questionnaire "sickness impact profile"	up to 6 month