Unique ID issued by UMIN | UMIN000040157 |
---|---|
Receipt number | R000045026 |
Scientific Title | 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 |
Date of disclosure of the study information | 2020/04/21 |
Last modified on | 2020/04/14 18:51:04 |
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
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
Japan |
hepatic encephalopathy
Hepato-biliary-pancreatic medicine |
Others
NO
We show that lubiprostone safely and effectively promotes defecation and significantly suppresses the onset and exacerbation of hepatic encephalopathy.
Safety,Efficacy
The following is the measurement, an item evaluating at point of start, 1, 3, 6 months.
serum NH3
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).
Observational
20 | years-old | <= |
80 | years-old | >= |
Male and Female
Patients with cirrhosis diagnosed with hepatic encephalopathy.
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
60
1st name | Hiroyuki |
Middle name | |
Last name | Ogawa |
Nara Medical University
Gastroenterology
634-8522
840 Shijo-cho, Kashihara-shi, Nara
0744223051
ogawah@naramed-u.ac.jp
1st name | Hiroyuki |
Middle name | |
Last name | Ogawa |
Nara Medical University
Gastroenterology
634-8522
840 Shijo-cho, Kashihara-shi, Nara
0744223051
ogawah@naramed-u.ac.jp
Nara Medical University Gastroenterology
Nothing
Other
Nara Medical University
840 Shijo-cho, Kashihara-shi, Nara
0744223051
ogawah@naramed-u.ac.jp
NO
2020 | Year | 04 | Month | 21 | Day |
Unpublished
Preinitiation
2019 | Year | 12 | Month | 10 | Day |
2020 | Year | 04 | Month | 21 | Day |
2024 | Year | 03 | Month | 31 | Day |
Obserbational Study
2020 | Year | 04 | Month | 14 | Day |
2020 | Year | 04 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045026