Low-dose Rifaximin in the Treatment of Covert Hepatic Encephalopathy

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

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.

Study Overview

• Status: Completed
• Conditions: Covert Hepatic Encephalopathy
• Intervention / Treatment: Drug: Rifaximin

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200003
      • Shanghai Changzheng Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: the high-dose rifaximin; The high-dose rifaximin group was given rifaximin 1200 mg/day for 8 weeks.	Drug: Rifaximin; The investigators use low-dose rifaximin for the treatment of patients with covert hepatic encephalopathy
Active Comparator: the low-dose rifaximinl group; The low-dose rifaximin group was given rifaximin 800 mg/day for 8 weeks.	Drug: Rifaximin; The investigators use low-dose rifaximin for the treatment of patients with covert hepatic encephalopathy
Placebo Comparator: the control group; The control group didn't receive rifaximin treatment	Drug: Rifaximin; The investigators use low-dose rifaximin for the treatment of patients with covert hepatic encephalopathy

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai Changzheng Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): May 31, 2020
• Study Completion (Actual): May 31, 2020

Study Registration Dates

• First Submitted: January 30, 2017
• First Submitted That Met QC Criteria: March 6, 2017
• First Posted (Actual): March 10, 2017

Study Record Updates

• Last Update Posted (Actual): July 1, 2021
• Last Update Submitted That Met QC Criteria: June 28, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: covert hepatic encephalopathy; low-dose rifaximin
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Liver Diseases; Brain Diseases, Metabolic; Hepatic Encephalopathy; Brain Diseases; Anti-Infective Agents; Gastrointestinal Agents; Anti-Bacterial Agents; Rifaximin
• Other Study ID Numbers: CZH0010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No