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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031567
Receipt No. R000036043
Scientific Title Evaluation of Leaky Gut Syndrome using by lactulose load test
Date of disclosure of the study information 2019/01/01
Last modified on 2018/03/04

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Basic information
Public title Evaluation of Leaky Gut Syndrome using by lactulose load test
Acronym Evaluation of Leaky Gut Syndrome
Scientific Title Evaluation of Leaky Gut Syndrome using by lactulose load test
Scientific Title:Acronym 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
1st name
Middle name
Last name Hiroaki Takaya
Organization Nara medical university
Division name 3rd department of interanal medicine
Zip code
Address 840,Shijo-cho, Kashihara, Nara
TEL 0744-22-3051
Email htky@naramed-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroaki Takaya
Organization Nara medical unversity
Division name 3rd department of interanal medicine
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
2018 Year 03 Month 10 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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