UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006638 |
|---|---|
| Receipt number | 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 00:02:38 |
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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.
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
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
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
y79y81@yahoo.co.jp
Sponsor or person
Institute
Ehime University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007853
