Low-dose Rifaximin in the Treatment of Covert Hepatic Encephalopathy
NCT ID: NCT03077217
Last Updated: 2021-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
40 participants
INTERVENTIONAL
2017-05-01
2020-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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the high-dose rifaximin
The high-dose rifaximin group was given rifaximin 1200 mg/day for 8 weeks.
Rifaximin
The investigators use low-dose rifaximin for the treatment of patients with covert hepatic encephalopathy
the low-dose rifaximinl group
The low-dose rifaximin group was given rifaximin 800 mg/day for 8 weeks.
Rifaximin
The investigators use low-dose rifaximin for the treatment of patients with covert hepatic encephalopathy
the control group
The control group didn't receive rifaximin treatment
Rifaximin
The investigators use low-dose rifaximin for the treatment of patients with covert hepatic encephalopathy
Interventions
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Rifaximin
The investigators use low-dose rifaximin for the treatment of patients with covert hepatic encephalopathy
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
70 Years
ALL
No
Sponsors
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Shanghai Changzheng Hospital
OTHER
Responsible Party
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Wei-Fen Xie
Director
Locations
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Shanghai changzheng Hospital
Shanghai, Shanghai Municipality, China
Countries
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References
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Zacharias HD, Kamel F, Tan J, Kimer N, Gluud LL, Morgan MY. Rifaximin for prevention and treatment of hepatic encephalopathy in people with cirrhosis. Cochrane Database Syst Rev. 2023 Jul 19;7(7):CD011585. doi: 10.1002/14651858.CD011585.pub2.
Other Identifiers
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CZH0010
Identifier Type: -
Identifier Source: org_study_id
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