UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027529 |
|---|---|
| Receipt number | R000031558 |
| Scientific Title | Metabolome analysis of gastroparesis |
| Date of disclosure of the study information | 2017/05/29 |
| Last modified on | 2019/12/01 08:27:40 |
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Basic information
Public title
Metabolome analysis of gastroparesis
Acronym
Metabolome analysis of gastroparesis
Scientific Title
Metabolome analysis of gastroparesis
Scientific Title:Acronym
Metabolome analysis of gastroparesis
Region
| Japan |
Condition
Condition
Functional dyspepsia with gastroparesis-associated symptoms
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify the factors associated with the pathophysiology of functional dyspepsia with gastroparesis-associated
symptoms using metabolome analysis.
Basic objectives2
Others
Basic objectives -Others
Clarify the pathophysiology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Identification of specific metabolite for gastroparesis-associated symptoms
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who underwent upper endoscopy and questionnaire for gastroparesis with written informed consent
Key exclusion criteria
The patients who had severe comorbidities (e.g. cancer, heart, respiratory, liver, and kidney disease) and diabetes and history of abdominal operation
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Fujiwara |
Organization
Osaka City University Graduate School of Medicine
Division name
Gastroenterology
Zip code
5458585
Address
1-4-3 Asahimachi, Abeno-ku, Osaka city, Osaka
TEL
06-6645-3811
m2079981@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | Fumio |
| Middle name | |
| Last name | Tanaka |
Organization
Osaka City University Graduate School of Medicine
Division name
Gastroenterology
Zip code
5458585
Address
1-4-3 Asahimachi, Abeno-ku, Osaka city, Osaka
TEL
06-6645-3811
Homepage URL
m2079981@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Osaka City University Review Board
Address
1-2-7, Asahimachi, Abeno-ku, Osaka city, Osaka
Tel
06-6646-6125
ethics@med.osaka-cu.ac.jp
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
| 2017 | Year | 05 | Month | 29 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
Unpublished
Number of participants that the trial has enrolled
17
Results
No significant findings for the patients with concomintant gastroparesis in functional dyspepsia.
Results date posted
| 2019 | Year | 12 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with functional dyspepsia
Participant flow
Patients who visited our hospital were enrolled.
Adverse events
None
Outcome measures
Metabolomic profile
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 03 | Month | 29 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 29 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational analysis
Management information
Registered date
| 2017 | Year | 05 | Month | 29 | Day |
Last modified on
| 2019 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031558
