Phase 2 study of Linaclotide as a novel treatment for minimal Hepatic Encephalopathy.

Improvement of Trail-Making Test-A in minimal Hepatic Encephalopathy treated by Linaclotide, a phase 2 study. - Linaclotide in minimal HE

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031200163

Enrollment

Registered

2020-10-19

Start date

2021-01-22

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

Chronic liver disease/ Liver cirrhosis / minimal hepatic encephalopathy

Interventions

Treating minimal hepatic encephalopathy patients by Linaclotide.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Liver cirrhosis patients with minimal hepatic encephalopathy

Exclusion criteria

Exclusion criteria: patients having hypersensitivity to Linaclotide a past history of bowel obstruction or peritonitis comorbidity of psychiatric disorder such as depression, masked depression, schizophrenia and dementia. patients recieving antibiotics within a week before starting Linaclotide. patients having active gastrointestinal bleeding

Design outcomes

Primary

Measure	Time frame
Improvement of number connection test-A	—

Secondary

Measure	Time frame
Improvement of number connection test-B serum ammonia level flapping tremor hepatic encephalopathy coma (West Haven Criteria) PSE index rate of change of PSE index bowel movement frequency, levels of consiousness general effectiveness evaluation	—

Contacts

Public ContactAsako Nogami

Yokohama City University Hospital

nogamia@yokohama-cu.ac.jp+81-45-787-2640

Outcome results

None listed

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