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

A prospective intervention study of the quality of life improvement effect of rifaximin administration in patients with non-alcoholic fatty liver disease (NAFLD) complicated by hyperammonemia with subclinical hepatic encephalopathy

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1041230103

Enrollment

Registered

2023-11-07

Start date

2023-09-12

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-alcoholic fatty liver disease (NAFLD)

Interventions

Forty-eight-week administration of rifaximin for non-alcoholic fatty liver disease complicated with hyperammonemia and covert hepatic encephalopathy.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
The change of SF-36 score by rifaximin administration	—

Secondary

Measure	Time frame
(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	—

Contacts

Public ContactNoritake Hidenao

Hamamatsu University Hospital

noritake@hama-med.ac.jp+81-53-435-2262

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026