UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025577 |
|---|---|
| Receipt number | R000029435 |
| Scientific Title | Development of a simple mucosal barrier evaluation method for GERD and FGIDs |
| Date of disclosure of the study information | 2017/01/16 |
| Last modified on | 2020/01/14 08:45:07 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Development of a simple mucosal barrier evaluation method for GERD and FGIDs
Acronym
Evaluation of mucosal barrier function in GERD and FGIDs
Scientific Title
Development of a simple mucosal barrier evaluation method for GERD and FGIDs
Scientific Title:Acronym
Evaluation of mucosal barrier function in GERD and FGIDs
Region
| Japan |
Condition
Condition
Gastroesophageal reflux disease, functional gastrointestinal disorders
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of gastrointestinal mucosal admittance/susceptance index
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gastrointestinal mucosal admittance/susceptance index in gastrointestinal disorders and healthy subjects
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Gastrointestinal mucosal conductance measurement under endoscopy
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
No symptomatic control
GERD
FD
IBS
Key exclusion criteria
1. Patients taking medicine (acid suppressants and prokinetics) more than 2 weeks
2. Patients who have alarm signs (vomiting, gastrointestinal bleeding etc.)
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Hiroto |
| Middle name | |
| Last name | Miwa |
Organization
Hyogo College of Medicine
Division name
Division of Gastroenterology, Department of Internal Medicine
Zip code
663-8501
Address
1-1 Mukogawa-cho, Nisinomiya, Hyogo
TEL
0798-45-6665
miwahgi@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Tadayuki |
| Middle name | |
| Last name | Oshima |
Organization
Hyogo College of Medicine
Division name
Division of Gastroenterology, Department of Internal Medicine
Zip code
663-8501
Address
1-1 Mukogawa-cho, Nisinomiya, Hyogo
TEL
0798-45-6665
Homepage URL
t-oshima@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Gastroenterology, Department of Internal Medicine
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
Hyogo College of Medicine
Address
1-1 Mukogawa-cho Nishinomiya Hyogo Japan
Tel
0798-45-6111
rinnri@hyo-med.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 | 01 | Month | 16 | 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
20
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
Completed
Date of protocol fixation
| 2016 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 08 | Day |
Last modified on
| 2020 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029435
