UMIN-CTR Clinical Trial

Basic information
Public title	Impact of esophageal barrier function on proton pump inhibitor-resistant non erosive reflux disease (PPI-resistant NERD): discovering of pathophysiology and establishment of new therapeutic strategy
Acronym	Impaired esophageal barrier function causes PPI-resistant NERD.
Scientific Title	Impact of esophageal barrier function on proton pump inhibitor-resistant non erosive reflux disease (PPI-resistant NERD): discovering of pathophysiology and establishment of new therapeutic strategy
Scientific Title:Acronym	Impaired esophageal barrier function causes PPI-resistant NERD.
Region	Japan

Condition
Condition	Proton pump inhibitor-resistant non erosive reflux disease (PPI-resistant NERD)
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the pathophysiology of proton pump inhibitor-resistant non erosive reflux disease by measuring of esophageal barrier function in the biospy specimen of the patients and comparing to that of healthy volunteers
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 upper and lower esophageal epithelium of esophageal barrier function by mini ussing chamber system among patients of PPI-resistant NERD, functional heart burn and healthy volunteer.
Key secondary outcomes	1. comparison of esophageal barrier function between patients with heart burn (PPI-resistant NERD and FH) and healthy volunteer. 2. comparison of esophageal tight junctional protein in the bisopy specimen among PPI-resistant NERD, FH and healthy volunteer. 3. validation of esophageal histopathological difference amaong PPI-resistant NERD, FH and healthy volunteer. 4. elucidating relationship with intraesophageal luminal pH and esophageal epithelial barrier function between PPI-resistant NERD and FH. 5. comparison of difference in esophageal reflux contents and epithelial barrier function between PPI-resistant NERD and FH

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
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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	<patient> 1. NERD and FH patietnts who fail to achieve remission of symptoms by daily dose of 20 mg rabeprazole for 8 weeks 2. Performance status 0 3. From 20 to 85 year-old patients, male:female=1:1 4. Outpatients of Tohoku university hospital from August 2017 until December 2010 5. Informed consent was obtained. <healthy volunteer> 1. Drug-free, no symptom 2. From 20 to 85 year-old patients, male:female=1:1 3. Informed consent was obtained.
Key exclusion criteria	<Only healthy volunteer> 1. Acid suppression drugs such as histamine 2 antagonist or PPI, Nsaids, steroids or immune suppression drugs were not administered 1 month before measurement of esophageal barrier function. <patients and volunteers> 2. scheduled or history of abdominal surgical operation 3. Patients who prohibited to underwent endoscopy 4. pregnancy 5. severe diseases 6. psychogenic diseases 7. Patients whom we decided inappropriate to join in this study.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kiyotaka Asanuma
Organization	Tohoku university graduate school of medicine
Division name	gastrotenterology
Zip code
Address	1-1 Seiryo machi Aobaku Sendai Miyagi, 980-8574
TEL	022-717-7171
Email	takaxeve2004rosso@yahoo.com

Public contact
Name of contact person	1st name Middle name Last name Kiyotaka Asanuma
Organization	Tohoku university graduate school of medicine
Division name	gastrotenterology
Zip code
Address	1-1 Seiryo machi Aobaku Sendai Miyagi, 980-8574
TEL	022-717-7171
Homepage URL	http://www.rinri.med.tohoku.ac.jp/portal
Email	takaxeve2004rosso@yahoo.com

Sponsor
Institute	Tohoku university graduate school of medicine dept. gastroenterology
Institute
Department

Funding Source
Organization	Tohoku university graduate school of medicine dept. gastroenterology
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	東北大学病院消化器内科

Other administrative information
Date of disclosure of the study information	2017 Year 07 Month 25 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
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	Preinitiation
Date of protocol fixation	2017 Year 07 Month 07 Day
Date of IRB
Anticipated trial start date	2017 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	no special information

Management information
Registered date	2017 Year 07 Month 20 Day
Last modified on	2017 Year 08 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032396

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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