UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effects on gut microbiome by taking protom pump inhibitor in the patients with gastroesophageal reflux disease
Title of the study (Brief title)	proton pmp inhibitor and gut microbiome
Region	Japan

Condition
Condition	Gastroesophageal reflux disease
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To identify the ffects on gut microbiome by using PPIs, we conducted this prospective study.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Microbiota profile at 7 days, 28 days and 56 days after starting PPI use
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	vonoprazan 20mg once per day for 28 days and 10mg for 28days
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	Not applicable
Gender	Male and Female
Key inclusion criteria	mild gastroesophageal reflux disease (The Los Angels Classification grade A or B)
Key exclusion criteria	Patients already taking proton pump inhibitor or antiacids
Target sample size	20

Research contact person
Name of lead principal investigator	Akiko Shiotani
Organization	Kawasaki Medical School
Division name	Gastroenterology
Address	577 Matsusima, Kurashiki city, Okayama, Japan
TEL	086-462-1111
Email	shiotani@med.kawasaki-m.ac.jp

Public contact
Name of contact person	Akiko Shiotani
Organization	Kawasaki Medical School
Division name	Gastroenterology
Address	577 Matsusima, Kurashiki city, Okayama, Japan
TEL	086-462-1111
Homepage URL
Email	shiotani@med.kawasaki-m.ac.jp

Sponsor
Institute	kawasaki Medical School
Institute
Department

Funding Source
Organization	kawasaki Medical School
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	2016 Year 09 Month 15 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 07 Month 27 Day
Anticipated trial start date	2016 Year 11 Month 01 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

Management information
Registered date	2016 Year 09 Month 14 Day
Last modified on	2018 Year 01 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027532