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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000028300 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | Proton pump inhibitor-resistant non erosive reflux disease (PPI-resistant NERD) | |
Classification by specialty |
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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 | |
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Interventions/Control_8 | |
Interventions/Control_9 | |
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 40 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | |
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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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
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Date of the first journal publication of results | |
Baseline Characteristics | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Preinitiation | ||||||
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Other | |
Other related information | no special information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |