Does oral administration of rifaximin improve the quality of life of patients with non-alcoholic fatty liver disease with hyperammonemia and covert hepatic encephalopathy?

JRCT ID: jRCT1041230103

Registered date:07/11/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Non-alcoholic fatty liver disease (NAFLD)
• Date of first enrollment: 12/09/2023
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Forty-eight-week administration of rifaximin for non-alcoholic fatty liver disease complicated with hyperammonemia and covert hepatic encephalopathy.

Outcome(s)

• Primary Outcome: The change of SF-36 score by rifaximin administration

Secondary Outcome

(1) The association with SF-36: Stroop test, number connection test, ammonia level, grip strength
(2) The following changes before and after treatment with rifaximin: Stroop test, number connection test, grip strength, white blood cell count, leukocyte fractionation, CRP, ammonia level, AST, ALT, GGT

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 90age old
• Gender: Both

Include criteria

1. Over 18-year-old and under 90-year-old
2. Patients who have been diagnosed with non-alcoholic fatty liver disease (NAFLD) by diagnostic imaging or histological diagnosis
3. Patients who are judged to be "abnormal" by the Stroop test or number connection test
4. Patients whose ammonia levels exceed the upper limit of the institutional standard range (66 ug/dL)
5. Those who have been able to obtain consent for participation in this research by signing a consent form by the person in question.

Exclude criteria

1. Overt hepatic encephalopathy
2. Positive for HCV antibodies
3. Positive for HBs antigen or HBc antibody
4. Positive for antinuclear antibodies or anti-mitochondrial antibodies
5. Alcohol drinking more than 30 g of ethanol per day for men and 20 g of ethanol per day for woman
6. Taking corticosteroids internally
7. Undergoing hormone therapy for breast cancer
8. Women who are pregnant or may become pregnant
9. Color blindness
10. Hypersensitive to rifaximin
11. Taking cyclosporine or ethinyl estradiol internally
12. The principal investigator or co-investigators deem it inappropriate to participate in this study.

Related Information

• Primary Sponsor: Kazuhito Kawata