Randomized controlled trial comparing zinc-rifaximin combination therapy with zinc monotherapy in liver cirrhosis patients with minimal hepatic encephalopathy

Randomized controlled trial comparing zinc-rifaximin combination therapy with zinc monotherapy in liver cirrhosis patients with minimal hepatic encephalopathy - Rifaximin-containing combination vs single-agent zinc in liver cirrhosis patients with minimal hepatic encephalopathy(MHE/zinc-rifa vs zinc )

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000036998

Enrollment

Registered

2019-06-10

Start date

2019-06-17

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

Liver cirrhosis with minimal hepatic encephalopathy

Interventions

Zinc (50mg/day) + rifaximin (120mg/day). For cases with the serum zinc level is less than 80 mcg/dl at 8 weeks of administration, the amount of zinc is increased to 100mg/day. Total administration per

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with hypozincemia and minimal encephalopathy due to liver cirrhosis, specifically patients who meet all the following conditions 1) Hypozincemia (<70mcg/dl) 2) Hyperammonemia (>50mcg/dl) 3) 2 or more abnormalities in Neuro-Psychological Tests 4) High signal of basal ganglia pallidus in T1-weighted image on head MRI

Exclusion criteria

Exclusion criteria: 1) Overt hepatic encephalopathy of West Haven Criteria grade 2 or more 2) Child-Pugh C 3) Past history of overt hepatic encephalopathy 4) Past history of digestive tract bleeding within one year 5) Severe hypoalbuminemia (<2.8g/dl) 6) Chronic kidney disease (serum Creatinine value >2.0mg/dl) 7) With other causes that lead to cognitive decline or impaired consciousness (brain atrophy, cerebral infarction, intracranial lesions such as brain tumors, drug abuse or alcohol dependence, etc.) 8) Infectious diseases that require treatment with antibiotics 9) Progressive hepatocellular carcinoma (hepatocellular carcinoma with vascular infiltration or extrahepatic metastasis, liver cancer incapable of local treatment)

Design outcomes

Primary

Measure	Time frame
Improvement rate of number connection test B (NCT-B)	—

Secondary

Measure	Time frame
1)Neuro-Psychological Tests (NCT-A, B, Figure position test, Digit symbol test, Block design test, Stroop test) 2)Achievement rate of serum zinc>80mcg/dl 3)Value, changes of serum zinc 3)Time to first breakthrough overt hepatic encephalopathy episode 4)Time to first hepatic encephalopathy-related hospitalization 5)Overall survival 6)Subgroup analysis of 2)3) classified by patients characteristics(Child-Pugh score, MELD score, FIB-4 index, Skeletal muscle index) 7) Improvement of high signal of head MRI T1-weighted image in the basal ganglia pallidus	—

Measure

Time frame

1)Neuro-Psychological Tests (NCT-A, B, Figure position test, Digit symbol test, Block design test, Stroop test) 2)Achievement rate of serum zinc>80mcg/dl 3)Value, changes of serum zinc 3)Time to first breakthrough overt hepatic encephalopathy episode 4)Time to first hepatic encephalopathy-related hospitalization 5)Overall survival 6)Subgroup analysis of 2)3) classified by patients characteristics(Child-Pugh score, MELD score, FIB-4 index, Skeletal muscle index) 7) Improvement of high signal of head MRI T1-weighted image in the basal ganglia pallidus

—

Countries

Japan

Contacts

Public ContactNobuhito Taniki

Keio University, School of Medicine Division of Gastroenterology and Hepatology

nobuhitotaniki@keio.jp+81-3-3353-1211

Outcome results

None listed

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