UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of Leaky Gut Syndrome using by lactulose load test
Title of the study (Brief title)	Evaluation of Leaky Gut Syndrome
Region	Japan

Condition
Condition	chronic liver disease(CLD), Inflammatory bowel disease(IBD)
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The relationshipi between Leaky Gut Syndrome, and CLD and IBD
Basic objectives2	Others
Basic objectives -Others	none
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The level of Leaky Gut is correlated with severity
Key secondary outcomes

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	Not applicable
Gender	Male and Female
Key inclusion criteria	1)>20 years old 2)The patients obtained the consent 3)>12 months of suvival periods 4)AST and ALT > 6 times from the facilities standards
Key exclusion criteria	1)The resection of intestinal 2)The pregnancy and lactaing 3)The outcome evaluation is difficult for patient's condition 4)The execution plan of achievement is difficult
Target sample size	40

Research contact person
Name of lead principal investigator	Hiroaki Takaya
Organization	Nara medical university
Division name	3rd department of interanal medicine
Address	840,Shijo-cho, Kashihara, Nara
TEL	0744-22-3051
Email	htky@naramed-u.ac.jp

Public contact
Name of contact person	Hiroaki Takaya
Organization	Nara medical unversity
Division name	3rd department of interanal medicine
Address	840,Shijo-cho, Kashihara, Nara
TEL	0744-22-3051
Homepage URL
Email	htky@naramed-u.ac.jp

Sponsor
Institute	Nare medical university
Institute
Department

Funding Source
Organization	self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	2019 Year 01 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 03 Month 10 Day
Anticipated trial start date	2018 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	nothing

Management information
Registered date	2018 Year 03 Month 04 Day
Last modified on	2018 Year 03 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036043