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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000006637
Receipt No. R000007850
Scientific Title The small intestine absorption test using the [1-13C] labeled substance, and a study of bacterial overgrowth in the intestine.
Date of disclosure of the study information 2011/10/31
Last modified on 2013/11/08

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Basic information
Public title The small intestine absorption test using the [1-13C] labeled substance, and a study of bacterial overgrowth in the intestine.
Acronym The small intestine absorption test using the [1-13C] labeled substance, and a study of bacterial overgrowth.
Scientific Title The small intestine absorption test using the [1-13C] labeled substance, and a study of bacterial overgrowth in the intestine.
Scientific Title:Acronym The small intestine absorption test using the [1-13C] labeled substance, and a study of bacterial overgrowth.
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 could be a risk factor for hepatic inflammation and hepatocarcinogenesis. We evaluate the alteration for absorption of fatty acids in the patients with liver cirrhosis with or without portal hypertension, and want to identify its mechanism. Moreover, we want to evaluate the association with bacterial overgrowth in intestine.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Time course of breath 13CO2 excretion after loading [1-13C]-labeled substances
Key secondary outcomes The area under the curve of total breath 13CO2 excretion

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
Food
Interventions/Control_1 We will enroll control subjects for this study from May, 2009 to April, 2014. After at least 12-h overnight fast, all subjects received substrates of [1-13C] labeled fatty acids or D-xylose using upper gastrointestinal tract endoscope in horizontal portion of duodenum. The breath samples were collected at before loading the substrates, and at every 15 min during first 30 min, then every 30 min during the following 5 hour 30 min (total was 360 min after loading).
For the breath samples, the ratio of 13CO2 divided by 12CO2 were analyzed by using non dispersive infrared spectrometry.
Interventions/Control_2 We will enroll patients with liver cirrhosis without portal hypertension for this study from May, 2009 to April, 2014. After at least 12-h overnight fast, all subjects received substrates of [1-13C] labeled fatty acids or D-xylose using upper gastrointestinal tract endoscope in horizontal portion of duodenum. The breath samples were collected at before loading the substrates, and at every 15 min during first 30 min, then every 30 min during the following 5 hour 30 min (total was 360 min after loading).
For the breath samples, the ratio of 13CO2 divided by 12CO2 were analyzed by using non dispersive infrared spectrometry.
Interventions/Control_3 We will enroll control subjects and patients with liver cirrhosis with portal hypertension for this study from May, 2009 to April, 2014. After at least 12-h overnight fast, all subjects received substrates of [1-13C] labeled fatty acids or D-xylose using upper gastrointestinal tract endoscope in horizontal portion of duodenum. The breath samples were collected at before loading the substrates, and at every 15 min during first 30 min, then every 30 min during the following 5 hour 30 min (total was 360 min after loading).
For the breath samples, the ratio of 13CO2 divided by 12CO2 were analyzed by using non dispersive infrared spectrometry.
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
90 years-old >
Gender Male and Female
Key inclusion criteria he people with or without liver cirrhosis who have a schedule to receive the endoscopic examination for stomach and intestine. All enrolled participants provided written informed consent to research testing under protocols approved by the Institutional Review Boards of Ehime University Hospital (approved number: 0904007).The study protocol conformed to the ethical guidelines of the Declaration of Helsinki.
Key exclusion criteria We exclude the patients with diabetes or abnormality of lipid metabolism. We also exclude the patients who could not receive the examination by upper gastrointestinal tract endoscope due to systemic condition.
Target sample size 100

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.com

Sponsor
Institute Ehime University Graduate School of Medicine
Institute
Department

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
2009 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 05 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 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007850

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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