Low-dose Rifaximin in the Treatment of Covert Hepatic Encephalopathy

• Sponsor: Shanghai Changzheng Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03077217
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 3
• Actual Duration (Months): 37
• Patients Per Site Per Month: 1.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Covert Hepatic Encephalopathy	Drug: Rifaximin	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Low-dose Rifaximin in the Treatment of Covert Hepatic Encephalopathy: A Randomized Open Controlled Study
• Actual Study Start Date: May 1, 2017
• Actual Primary Completion Date: May 31, 2020
• Actual Study Completion Date: May 31, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Percentage of patients showing covert hepatic encephalopathy reversal [up to 6 months]

   the percentage of patients showing covert hepatic encephalopathy reversal

2. health-related quality of life improvement [up to 6 month]

   complete the questionnaire "sickness impact profile"

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai changzheng Hospital	Shanghai	Shanghai	China	200003

Sponsors and Collaborators

• Shanghai Changzheng Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wei-Fen Xie, Director, Shanghai Changzheng Hospital
• ClinicalTrials.gov Identifier: NCT03077217
• Other Study ID Numbers: CZH0010
• First Posted: Mar 10, 2017
• Last Update Posted: Jul 1, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Wei-Fen Xie, Director, Shanghai Changzheng Hospital: covert hepatic encephalopathy; low-dose rifaximin
• Additional relevant MeSH terms: Hepatic Encephalopathy; Brain Diseases; Rifaximin

Study Results

No Results Posted as of Jul 1, 2021