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Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000006638
Receipt No. R000007853
Scientific Title The study for small intestinal absorption by using intestinal specimen
Date of disclosure of the study information 2011/10/31
Last modified on 2013/11/09

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Basic information
Public title The study for small intestinal absorption by using intestinal specimen
Acronym The study for small intestinal absorption by using intestinal specimen
Scientific Title The study for small intestinal absorption by using intestinal specimen
Scientific Title:Acronym The study for small intestinal absorption by using intestinal specimen
Region
Japan

Condition
Condition Liver cirrhosis, portal hypertension
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Dietary fatty acid is an important risk factor for the development of hepatic inflammation and the hepatocarcinogenesis.
We estimated the alteration for absorption of fatty acid in the patients with liver cirrhosis.
We aimed to determine the alteration of associated molecule for the absorption of fatty acid by using small intestinal specimen.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Analysis of the molecules associated with the absorption of fatty acids in the patients with liver cirrhosis with or without portal hypertension.
Key secondary outcomes Immunohistochemical analysis of the intestinal specimen in the patients with liver cirrhosis with or without portal hypertension. Moreover, analysis of the protein and mRNA levels of intestinal molecules associated with the transport of long-chain fatty acids in the patients with liver cirrhosis with or without portal hypertension.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 The subjects with written informed consent are enrolled in this study from November, 2010 to April 2014. The subjects are consisted with control subjects. Those subjects are examined small intestine with the small intestine by using double-balloon endoscope (EN-450P5/20, or EN-450T5/W, FUJIFILM Medical Co., Ltd., Tokyo, Japan), and biopsy specimens are collected. We exained the expression of intestinal molecules associated with the absorption of fatty acids. We also examine the immunohistochemical analysis with the specimens.
Interventions/Control_2 The subjects with written informed consent are enrolled in this study from November, 2010 to April 2014. The subjects are consisted with patients with liver cirrhosis without portal hypertension. Those subjects are examined small intestine with the small intestine by using double-balloon endoscope (EN-450P5/20, or EN-450T5/W, FUJIFILM Medical Co., Ltd., Tokyo, Japan), and biopsy specimens are collected. We exained the expression of intestinal molecules associated with the absorption of fatty acids. We also examine the immunohistochemical analysis with the specimens.
Interventions/Control_3 The subjects with written informed consent are enrolled in this study from November, 2010 to April 2014. The subjects are consisted patients with liver cirrhosis with portal hypertension. Those subjects are examined small intestine with the small intestine by using double-balloon endoscope (EN-450P5/20, or EN-450T5/W, FUJIFILM Medical Co., Ltd., Tokyo, Japan), and biopsy specimens are collected. We exained the expression of intestinal molecules associated with the absorption of fatty acids. We also examine the immunohistochemical analysis with the specimens.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
85 years-old >
Gender Male and Female
Key inclusion criteria The people with or without liver cirrhosis who have a schedule to receive small-intestinal endoscopy.
All enrolled participants provided written informed consent for the study under the protocols approved by the Institutional Review Boards of Ehime University Hospital (approved number: 1011004).
The study protocol conformed to the ethical guidelines of the Declaration of Helsinki.
Key exclusion criteria We exclude a patient who has a risk for bleeding by taking the intestinal biopsy specimen (for example, bleeding tendency, taking the anticoagulant drug).
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Morikazu Onji
Organization Ehime University Graduate School of Medicine
Division name Department of Gastroenterology and Metabology
Zip code
Address Toon City, Ehime 791-0295, Japan
TEL +81-89-960-5308
Email y79y81@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yasunori Yamamoto
Organization Ehime University Graduate School of Medicine
Division name Department of Gastroenterology and Metabology
Zip code
Address Toon City, Ehime 791-0295, Japan
TEL +81-89-960-5308
Homepage URL
Email y79y81@yahoo.co.jp

Sponsor
Institute Ehime University Graduate School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization None
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
2011 Year 10 Month 31 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 Enrolling by invitation
Date of protocol fixation
2010 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 01 Day
Last follow-up date
2015 Year 03 Month 01 Day
Date of closure to data entry
2015 Year 03 Month 01 Day
Date trial data considered complete
2015 Year 03 Month 01 Day
Date analysis concluded
2015 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 10 Month 31 Day
Last modified on
2013 Year 11 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007853


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