UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028300 |
|---|---|
| Receipt number | R000032396 |
| 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 |
| Date of disclosure of the study information | 2017/07/25 |
| Last modified on | 2017/08/15 20:07:37 |
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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
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
<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
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
takaxeve2004rosso@yahoo.com
Sponsor or person
Institute
Tohoku university graduate school of medicine dept. gastroenterology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032396
