UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Metabolic analysis of eosinophilic esophagitis
Title of the study (Brief title)	Metabolic analysis of eosinophilic esophagitis
Region	Japan

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

Objectives
Narrative objectives1	To investigate characteristic serum metabolite of eosinophilic esophagitis using metabolic analysis
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Metabolic analysis of serum taken from patients of eosinophilic esophagitis
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Eosinophilic esophagitis (EoE) 1. Patients who suffer from dysphagia and have 15 or more eosinophils/HPF in esophageal epithelium 2. Patients who provide writen informed consent 3. Patients 18 years or older Non EoE 1. Subjects without dysphagia and characteristic endoscopic findings of EoE 2. Subjects who provide writen informed consent 3. Subjects 18 years or older
Key exclusion criteria	EoE/Non EOE 1. Sujects who have severe comorbidity 2. Subjects who have history of gastrointestinal surgery except for endoscopic treatment such as polypectomy and ESD 3. Subjects who are not eligible for participation judged by a doctor
Target sample size	40

Research contact person
Name of lead principal investigator	Yasuhiro Fujiwara
Organization	Osaka City University Graduate School of Medicine
Division name	Department of Gastroenterology
Address	1-4-3 Asahimachi, Abenoku, Osaka 545-8585
TEL	06-6645-3811
Email	yasu@med.osaka-cu.ac.jp

Public contact
Name of contact person	Akinari Sawada
Organization	Osaka City University Graduate School of Medicine
Division name	Department of Gastroenterology
Address	1-4-3 Asahi-machi, Abeno-ku,Osaka 545- 8585, Japan
TEL	06-6645-3811
Homepage URL
Email	m1164972@med.osaka-cu.ac.jp

Sponsor
Institute	Department of Gastroenterology, Osaka City University Graduate School of Medicine
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)

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	2017 Year 04 Month 05 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 03 Month 29 Day
Anticipated trial start date	2017 Year 04 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	nothing in particular

Management information
Registered date	2017 Year 04 Month 03 Day
Last modified on	2017 Year 04 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030809