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

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 - Impaired esophageal barrier function causes PPI-resistant NERD.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000028300

Enrollment

Registered

2017-07-25

Start date

2017-08-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Proton pump inhibitor-resistant non erosive reflux disease (PPI-resistant NERD)

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactKiyotaka Asanuma

Tohoku university graduate school of medicine gastrotenterology

takaxeve2004rosso@yahoo.com022-717-7171

Outcome results