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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014792
Receipt No. R000017119
Scientific Title Intestinal absorption test using 13C-labeled compounds
Date of disclosure of the study information 2014/08/08
Last modified on 2017/08/09

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Basic information
Public title Intestinal absorption test using 13C-labeled compounds
Acronym Intestinal absorption test using 13C-labeled compounds
Scientific Title Intestinal absorption test using 13C-labeled compounds
Scientific Title:Acronym Intestinal absorption test using 13C-labeled compounds
Region
Japan

Condition
Condition non-alcoholic steatohepatitis
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 reveal changes in dietary fatty acid absorption kinetics of the non-alcoholic steatohepatitis patients
Basic objectives2 Others
Basic objectives -Others nothing
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes nothing
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Using endoscopy, we spray 13C labeling reagent in duodenum.
13C labeling reagent consists of mixture of 13C- palmitic acid 200mg and 20ml RACOL®.Patients' breath is collected up to 360 minutes every 30 minutes. Then, the 13CO2 in exhaled breath is measured using an infrared spectrometer UBit-IR200.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Healthy people or patients with metabolic syndrome including NASH
Key exclusion criteria Egg-allergic patient

Patients that can not perform properly breath sampling

Patients that can not perform upper gastrointestinal endoscopy because of systemic state

Patients with chronic liver disease other than NASH
Target sample size 110

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroki Utsunomiya
Organization Ehime University Graduate School of Medicine
Division name Departments of Gastroenterology and Metabology
Zip code
Address Minamigata 1696-1 Rural 803, Toon, Ehime
TEL 08029725163
Email lopp_august@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroki Utsunomiya
Organization Ehime University Graduate School of Medicine
Division name Departments of Gastroenterology and Metabology
Zip code
Address Shitsukawa 454, Toon, Ehime
TEL 0899605308
Homepage URL
Email lopp_august@yahoo.co.jp

Sponsor
Institute Ehime University, Departments of Gastroenterology and Metabology
Institute
Department

Funding Source
Organization Departments of Gastroenterology and Metabology
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
2014 Year 08 Month 08 Day

Related information
URL releasing protocol https://link.springer.com/article/10.1007%2Fs00535-016-1298-6
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/28062946
Number of participants that the trial has enrolled
Results
13CO2 excretion was significantly higher in e-NASH patients than in the control subjects and a-NASH patients.
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 Completed
Date of protocol fixation
2014 Year 08 Month 08 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 08 Day
Last follow-up date
2017 Year 08 Month 01 Day
Date of closure to data entry
2017 Year 08 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 08 Month 07 Day
Last modified on
2017 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017119

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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