UMIN-CTR Clinical Trial

Basic information
Public title	The exploratory study on change of the gutmicrobiota in Rabeprazole divided doses:Direction crossover controlled trial in front of an open label
Acronym	The exploratory study on change of the gutmicrobiota in the Rabeprazole administration
Scientific Title	The exploratory study on change of the gutmicrobiota in Rabeprazole divided doses:Direction crossover controlled trial in front of an open label
Scientific Title:Acronym	The exploratory study on change of the gutmicrobiota in the Rabeprazole administration
Region	Japan

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

Objectives
Narrative objectives1	The aim of this study was to determine the association between intragastric pH and change of the intestinal bacterial flora by changing the proton pump inhibitor doses.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Correlation of intragastric pH and enteric bacteria profile.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Subjects are 12 Helicobacter pylori infection-negative healthy Volunteers.Subjects take rabeprazole 10 mg o.d for 7 days. We conduct examination of 24 hours pH monitoring and flora sampling on the seventh day.
Interventions/Control_2	Subjects are 12 Helicobacter pylori infection-negative healthy Volunteers.Subjects take rabeprazole 5mg o.d for 7 days. We conduct examination of 24 hours pH monitoring and flora sampling on the seventh day.
Interventions/Control_3	Subjects are 12 Helicobacter pylori infection-negative healthy Volunteers.Subjects take rabeprazole 5mg bid for 7 days. We conduct examination of 24 hours pH monitoring and flora sampling on the seventh day.
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	50 years-old >=
Gender	Male and Female
Key inclusion criteria	1.With consent 2.From 20 years old to 50 years old. 2.H.pylori infection-negative. 3.Performance status:ECOG 0.
Key exclusion criteria	1.No consent 2.With the drug including a suppressant acid-secreting for the past one month. 3.With probiotics (medicine for intestinal disorders) or the antimicrobial agent for the past one month. 4.With grapefruits for the past two weeks. 5.With operating treatment for upper gastrointestinal disease including esophagus and stomach. 6.During pregnancy or nursing.
Target sample size	12

Research contact person
Name of lead principal investigator	1st name Middle name Last name Mitsushige Sugimoto
Organization	Shiga University of Medical Science Hospital
Division name	Division of Digestive Endoscopy
Zip code
Address	Seta Tsukinowa-cho, Otsu, Shiga, JAPAN,520-2192
TEL	077-548-2618
Email	sugimo@belle.shiga-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Mitsushige Sugimoto
Organization	Shiga University of Medical Science Hospital
Division name	Division of Digestive Endoscopy
Zip code
Address	Seta Tsukinowa-cho, Otsu, Shiga, JAPAN,520-2192
TEL	077-548-2618
Homepage URL
Email	sugimo@belle.shiga-med.ac.jp

Sponsor
Institute	Shiga University of Medical Science
Institute
Department

Funding Source
Organization	Shiga University of Medical Science
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
Address
Tel
Email

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	2018 Year 04 Month 01 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	Completed
Date of protocol fixation	2018 Year 03 Month 29 Day
Date of IRB	2018 Year 03 Month 29 Day
Anticipated trial start date	2018 Year 03 Month 29 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 03 Month 31 Day
Last modified on	2021 Year 05 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036556