UMIN-CTR Clinical Trial

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
Email	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
Email	eikichi@intmed3.med.kyushu-u.ac.jp

Sponsor
Institute	kyushu university
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026956