Prospective clinical study aiming at the improvement of hepatic encephalopathy and hepatic functional reserve of patients with liver cirrhosis by the secretory laxative agate lubiprostone

Prospective clinical study aiming at the improvement of hepatic encephalopathy and hepatic functional reserve of patients with liver cirrhosis by the secretory laxative agate lubiprostone - Improvement of hepatic encephalopathy and hepatic functional reserve by lubiprostone

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000040157

Enrollment

Registered

2020-04-21

Start date

2020-04-21

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

hepatic encephalopathy

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with cirrhosis diagnosed with hepatic encephalopathy.

Exclusion criteria

Exclusion criteria: 1. <=19 y.o. or 81 y.o.<= 2. pregnancy or breast-feeding 3. have ever taken lubiprostone 4. heart failure (admission by 6 months) 5. renal severe failure(eGFR<30 ml/min/1.73m2) 6. serum sodium <125mEq/L or >150mEq/L 7. Cerebral infarction without paralysis and lacunar infarction 8. Dementia more than Performance Status 2 9. abdominal surgery career (stomach segmental resection or intestinal tract excision) 10. with taking opioid agents 11. change or increase diuretic agents for obserbation period 12. with infectious disease or gastrointestinal breeding 13. with malignant tumor 14. patients of refusal this trial 15. The patient who judged that this study responsibility doctor and allotment doctor were inadequate

Design outcomes

Primary

Measure	Time frame
The following is the measurement, an item evaluating at point of start, 1, 3, 6 months. serum NH3	—

Secondary

Measure	Time frame
The following is the measurement, an item evaluating at point of start, 1, 3, 6 months. Blood exams; Blood count, prothrombin time, various blood biochemistry [Alb, AST, ALT, ALP, gamma-GTP, T-Bil, Cre, CRP, NH3], endotoxin-related marker (EAA, CD163, CD206) Simple inspection: Number connection test, Stroop test, CLD questionnaire with or without adverse event, stool frequency and status (ever average of 2 weeks), the weight change. It is an item to evaluate at six months at the point of start as follows. An examination for feces: An enterobacterial flora change, feces organic acid analysis. Confirm the following items by ELISA (TNF-alpha, IL-6, IL-12, IL-10, TGF-beta).	—

Measure

Time frame

The following is the measurement, an item evaluating at point of start, 1, 3, 6 months. Blood exams; Blood count, prothrombin time, various blood biochemistry [Alb, AST, ALT, ALP, gamma-GTP, T-Bil, Cre, CRP, NH3], endotoxin-related marker (EAA, CD163, CD206) Simple inspection: Number connection test, Stroop test, CLD questionnaire with or without adverse event, stool frequency and status (ever average of 2 weeks), the weight change. It is an item to evaluate at six months at the point of start as follows. An examination for feces: An enterobacterial flora change, feces organic acid analysis. Confirm the following items by ELISA (TNF-alpha, IL-6, IL-12, IL-10, TGF-beta).

—

Countries

Japan

Contacts

Public ContactHiroyuki Ogawa

Nara Medical University Gastroenterology

ogawah@naramed-u.ac.jp0744223051

Outcome results