UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023397 |
|---|---|
| Receipt number | R000026956 |
| Scientific Title | An analysis of permeability of the gastrointestinal epithelium in functional dyspepsia (FD) patients |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2020/01/31 19:03:02 |
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Basic information
Public title
An analysis of permeability of the gastrointestinal epithelium in functional dyspepsia (FD) patients
Acronym
An analysis of permeability of the gastrointestinal epithelium in FD patients
Scientific Title
An analysis of permeability of the gastrointestinal epithelium in functional dyspepsia (FD) patients
Scientific Title:Acronym
An analysis of permeability of the gastrointestinal epithelium in FD patients
Region
| Japan |
Condition
Condition
Functional dyspepsia
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of mucosal impedance of epithelium of the upper gastrointestinal tract in Functional dyspepsia patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of whether or not mucosal impedance is related to the functional dyspepsia
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Tissue Conductance Meter in FD patients
Interventions/Control_2
Tissue Conductance Meter in non-FD patients
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
Patients
1. Patients who are diagnosed functional dyspepsia or who are suspected of functional dyspepsia by Rome III criteria.
2. Patients from whom written informed consent is obtained.
3. Patients who are older than 20 years old.
4. Patients who are taking proton pump inhibitor, H2 antagonist or mucosal protective agent are also included.
non-FD patients
1. Patients who are not diagnosed functional dyspepsia by Rome III criteria.
2. Patients from whom written informed consent is obtained.
3. Patients who are older than 20 years old.
4. Patients who are diagnosed functional dyspepsia are also included even if they have organic disease.
Key exclusion criteria
1. Patients who are judged as contraindication for endoscopy.
2. Patients who are judged as being inappropriate for this study by their medical doctor.
3. Patients from whom written informed consent is not obtained.
4. Patients who have organic diseases after endoscopy and which could cause the upper abdominal symptoms.
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Ogawa |
Organization
Kyushu University Graduate School of Medical Sciences
Division name
Department of Medicine and Bioregulatory Science
Zip code
8128582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
092-642-5286
yogawa@intmed3.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Eikichi |
| Middle name | |
| Last name | Ihara |
Organization
Kyushu University Graduate School of Medical Sciences
Division name
Department of Medicine and Bioregulatory Science
Zip code
8128582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
092-642-5286
Homepage URL
eikichi@intmed3.med.kyushu-u.ac.jp
Sponsor or person
Institute
kyushu university
Institute
Department
Personal name
Funding Source
Organization
kyushu university
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
KYUSHU UNIVERSITY Center for Clinical and Translational Research(CCTR)
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, JAPAN
Tel
092-642-5774
byskenkyu@jimu.kyushu-u.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
| 2016 | Year | 08 | Month | 01 | 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
58
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 | 08 | Month | 02 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 29 | Day |
Last modified on
| 2020 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026956
