UMIN-CTR Clinical Trial

Basic information
Public title	Effect of salivary secretion on the onset of reflux esophagitis
Acronym	Salivary secretion and refractory reflux esophagitis
Scientific Title	Effect of salivary secretion on the onset of PPI-resistant severe reflux esophagitis
Scientific Title:Acronym	Salivary secretion and refractory reflux esophagitis
Region	Japan

Condition
Condition	Reflux esophagitis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Effect of salivary secretion (volume, pH, acid-buffering capacity) on the onset of PPI-resistant severe reflux esophagitis
Basic objectives2	Others
Basic objectives -Others	Effect of salivary epidermal growth factor (EGF) on the onset of PPI-resistant severe reflux esophagitis
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Volume of stimulated saliva pH of stimulated saliva acid-buffering capacity salivary epidermal growth factor (EGF) concentration
Key secondary outcomes

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patientes who have had standard-dose oral PPI therapy over 8 weeks 2. Patients who have been diagnosed with severe reflux esophagitis before PPI therapy 3. Pylori negative patients 4. Patients who have not been diagnosed with gastrotic mucosal atrophy (C-1 or C-2) 5. Patiens who have endoscopic hernia bigger than 2cm
Key exclusion criteria	except as mentioned above
Target sample size	25

Research contact person
Name of lead principal investigator	1st name Katsuhiko Middle name Last name Iwakiri
Organization	Nippon Medical School
Division name	Department of Gastroenterology
Zip code	113-8603
Address	1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL	03-3822-2131
Email	k-iwa@nms.ac.jp

Public contact
Name of contact person	1st name Tomohide Middle name Last name Tanabe
Organization	Nippon Medical School
Division name	Department of Gastroenterology
Zip code	113-8603
Address	1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL	03-3822-2131
Homepage URL
Email	tanabe@nms.ac.jp

Sponsor
Institute	Nippon Medical School Hospital
Institute
Department

Funding Source
Organization	None
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	Nippon Medical School Hospital
Address	1--1-5 Sendagi, Bunkyo-ku, Tokyo
Tel	03-3822-2131
Email	tanabe@nms.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	2020 Year 06 Month 19 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	Terminated
Date of protocol fixation	2019 Year 11 Month 01 Day
Date of IRB	2019 Year 12 Month 09 Day
Anticipated trial start date	2020 Year 01 Month 10 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The effect of salivary secretion on the onset of PPI-resistant severe reflux esophagitis has not been examined. In this study, the influences of stimulated saliva secretion and salivary EGF associated with healing of esophageal mucosal break on the development of PPI-resistant severe reflux esophagitis were investigated.

Management information
Registered date	2020 Year 06 Month 17 Day
Last modified on	2021 Year 01 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046245