UMIN-CTR Clinical Trial

Basic information
Public 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
Acronym	Improvement of hepatic encephalopathy and hepatic functional reserve by lubiprostone
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
Scientific Title:Acronym	Improvement of hepatic encephalopathy and hepatic functional reserve by lubiprostone
Region	Japan

Condition
Condition	hepatic encephalopathy
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We show that lubiprostone safely and effectively promotes defecation and significantly suppresses the onset and exacerbation of hepatic encephalopathy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The following is the measurement, an item evaluating at point of start, 1, 3, 6 months. serum NH3
Key secondary outcomes	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).

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with cirrhosis diagnosed with hepatic encephalopathy.
Key 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
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Hiroyuki Middle name Last name Ogawa
Organization	Nara Medical University
Division name	Gastroenterology
Zip code	634-8522
Address	840 Shijo-cho, Kashihara-shi, Nara
TEL	0744223051
Email	ogawah@naramed-u.ac.jp

Public contact
Name of contact person	1st name Hiroyuki Middle name Last name Ogawa
Organization	Nara Medical University
Division name	Gastroenterology
Zip code	634-8522
Address	840 Shijo-cho, Kashihara-shi, Nara
TEL	0744223051
Homepage URL
Email	ogawah@naramed-u.ac.jp

Sponsor
Institute	Nara Medical University Gastroenterology
Institute
Department

Funding Source
Organization	Nothing
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nara Medical University
Address	840 Shijo-cho, Kashihara-shi, Nara
Tel	0744223051
Email	ogawah@naramed-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2020 Year 04 Month 21 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2019 Year 12 Month 10 Day
Date of IRB
Anticipated trial start date	2020 Year 04 Month 21 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Obserbational Study

Management information
Registered date	2020 Year 04 Month 14 Day
Last modified on	2020 Year 04 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045026