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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028693
Receipt No. 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

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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
Email 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
Email takaxeve2004@aurora.ocn.ne.jp

Sponsor
Institute Division of Gastroenterology
Tohoku University Graduate School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032843

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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