UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006637
Receipt number 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 23:57:16

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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 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


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

Value
https://center6.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