UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028693 |
|---|---|
| Receipt number | R000032843 |
| Scientific Title | Impact of Impaired barrier function in duodenal mucosa to functional dyspepsia: discovering the pathophysiology and developing new therapeutic strategy |
| Date of disclosure of the study information | 2017/08/16 |
| Last modified on | 2019/08/20 17:58:57 |
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Basic information
Public title
Impact of Impaired barrier function in duodenal mucosa to functional dyspepsia: discovering the pathophysiology and developing new therapeutic strategy
Acronym
Impaired barrier function in duodenum causes functional dyspepsia (FD)
Scientific Title
Impact of Impaired barrier function in duodenal mucosa to functional dyspepsia: discovering the pathophysiology and developing new therapeutic strategy
Scientific Title:Acronym
Impaired barrier function in duodenum causes functional dyspepsia (FD)
Region
| Japan |
Condition
Condition
functional dyspepsia (FD)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the mechanism of functional dyspepsia, focusing duodenal mucosal barrier function
Basic objectives2
Others
Basic objectives -Others
pathophysiology
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of difference in duodenal barrier function between FD patients and healthy volunteer
Key secondary outcomes
Comparison of the difference in duodenal barrier function among FD with or without non erosive reflux disease (NERD) and healthy volunteer
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
measuring duodenal barrier function in FD patients, using mini ussing chamber system, and is compared to that in healthy volunteer.
Interventions/Control_2
mRNA is extracted from duodenal tissue, which is used for gene expression analysis in tight junctinal proteins and its regulatory factors.
Interventions/Control_3
Duodenal histological changes are evaluated with microscopical analysis. Protein expression is measured with immnohistochemical method.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
FD patients
1. 30 FD patients (Male/Female=1:1) who matches Rome IV criteria.
2. Performance status (PS) 0
3. age; 20 to 85 y
4. term; from 2017.9 to 2020 12
5. Informed consent was obtained
Healthy volunteer
1. no medication, no symptom
2. PS0
3. age; from 20 to 69 y
4. Informed consent was obtained
Key exclusion criteria
Only healthy volunteer
1. medication such as acid suppressive drug, Nsaids, steroids or immune suppressive drug 1 month prior to the study
All participants
1. past history of or scheduled abdominal surgery
2. forbidden in endoscopic examination (e.g. coagulation disorder)
3. pregnancy
4. severe healthy status
5. psychological disorder
6. those who are judged inappropriate to entry the study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Koike |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Gastroenterology
Zip code
980-8574
Address
1-1 Seiryomach Aobaku Sendai MIyagi, 980-8574
TEL
022-717-7171
tkoike@rd5.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Kiyotaka |
| Middle name | |
| Last name | Asanuma |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Gastroenterology
Zip code
980-8574
Address
1-1 Seiryomach Aobaku Sendai MIyagi, 980-8574
TEL
022-717-7171
Homepage URL
http://www.rinri.med.tohoku.ac.jp/portal
takaxeve2004@aurora.ocn.ne.jp
Sponsor or person
Institute
Division of Gastroenterology
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Gastroenterology
Tohoku University Graduate School of 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
Tohoku University Graduate School of Medicine
Address
1-1 Seiryomach Aobaku Sendai Miyagi
Tel
022-717-7171
takaxeve2004@aurora.ocn.ne.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
東北大学大学院消化器病態学分野
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | 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
Results
TEER in duodenal epithelium was decreased more than that in healthy volunteer against weaky acid stimulation.
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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 16 | Day |
Last modified on
| 2019 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032843
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