Back to resultsLow-dose Rifaximin in the Treatment of Covert Hepatic Encephalopathy
Primary Purpose
Covert Hepatic Encephalopathy
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Rifaximin
Sponsored by
About this trial
This is an interventional treatment trial for Covert Hepatic Encephalopathy focused on measuring covert hepatic encephalopathy, low-dose rifaximin
Eligibility Criteria
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
Sites / Locations
- Shanghai changzheng Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
the high-dose rifaximin
the low-dose rifaximinl group
the control group
Arm Description
The high-dose rifaximin group was given rifaximin 1200 mg/day for 8 weeks.
The low-dose rifaximin group was given rifaximin 800 mg/day for 8 weeks.
The control group didn't receive rifaximin treatment
Outcomes
Primary Outcome Measures
Percentage of patients showing covert hepatic encephalopathy reversal
the percentage of patients showing covert hepatic encephalopathy reversal
health-related quality of life improvement
complete the questionnaire "sickness impact profile"
Secondary Outcome Measures
Full Information
NCT ID
NCT03077217
First Posted
January 30, 2017
Last Updated
June 28, 2021
Sponsor
Shanghai Changzheng Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03077217
Brief Title
Low-dose Rifaximin in the Treatment of Covert Hepatic Encephalopathy
Official Title
Low-dose Rifaximin in the Treatment of Covert Hepatic Encephalopathy: A Randomized Open Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
May 31, 2020 (Actual)
Study Completion Date
May 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Changzheng Hospital
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covert Hepatic Encephalopathy
Keywords
covert hepatic encephalopathy, low-dose rifaximin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
the high-dose rifaximin
Arm Type
Active Comparator
Arm Description
The high-dose rifaximin group was given rifaximin 1200 mg/day for 8 weeks.
Arm Title
the low-dose rifaximinl group
Arm Type
Active Comparator
Arm Description
The low-dose rifaximin group was given rifaximin 800 mg/day for 8 weeks.
Arm Title
the control group
Arm Type
Placebo Comparator
Arm Description
The control group didn't receive rifaximin treatment
Intervention Type
Drug
Intervention Name(s)
Rifaximin
Intervention Description
The investigators use low-dose rifaximin for the treatment of patients with covert hepatic encephalopathy
Primary Outcome Measure Information:
Title
Percentage of patients showing covert hepatic encephalopathy reversal
Description
the percentage of patients showing covert hepatic encephalopathy reversal
Time Frame
up to 6 months
Title
health-related quality of life improvement
Description
complete the questionnaire "sickness impact profile"
Time Frame
up to 6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Shanghai changzheng Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200003
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Low-dose Rifaximin in the Treatment of Covert Hepatic Encephalopathy
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