UMIN-CTR Clinical Trial

Basic information
Public title	Change of microbiota of oral cavity, stomach and intestine by administration of lansoprazole and vonoprazan
Acronym	Change of microbiota by lansoprazole and vonoprazan
Scientific Title	Change of microbiota of oral cavity, stomach and intestine by administration of lansoprazole and vonoprazan
Scientific Title:Acronym	Change of microbiota by lansoprazole and vonoprazan
Region	Japan

Condition
Condition	Healthy volunteers
Classification by specialty	Medicine in general Gastroenterology Infectious disease Geriatrics
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To clarify changes of microbiota in oral cavity, stomach and intestine by administration of lansoprazole and vonoprazan
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	Changes of microbiota in oral cavity, stomach and intestine between before and after administration of lansoprazole and vonoprazan
Key secondary outcomes	(1) Change of serum gastrin level

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	1. Lansoprazole 30mg once daily dosing 28 days 2. Washout periods: 28 days 3. Vonoprazan 20mg once daily dosing 28 days
Interventions/Control_2	1. Vonoprazan 20mg once daily dosing 28 days 2. Washout periods: 28 days 3. Lansoprazole 30mg once daily dosing 28 days
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	50 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Healthy volunteers at age of 20-50 years old with informed consent 2. Performance status: 0 3. H. pylori-negative 4. CYP2C19 genotype: poor metabolizer and rapid metabolizer
Key exclusion criteria	1. With medication of anti-microbial agents within three months. 2. With medication of anti-gastric acid inhibitory drug within three months. 3. With malignant diseases and severe complications 4. With mediaction of drug in relation with CYP3A4 pathway 5. With medication of corticosteroid 6. With active peptic ulcer 7. With severe complication, such as heart failure, renal failure and respiratory failure 8. With allergy for lansoprazole or vonoprazan 9. H. pylori-positive patients 10. Pregnancy 11. No informed consent
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Akira Andoh
Organization	Shiga University of Medical Science
Division name	Division of Gastroenterology
Zip code
Address	Seta Tsukinowa-cho, Otsu, Shiga
TEL	077-548-2217
Email	hqmed2@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
TEL	077-548-2618
Homepage URL
Email	sugimo@belle.shiga-med.ac.jp

Sponsor
Institute	Shiga University of Medical Science Hospital
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	2015 Year 12 Month 15 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	2015 Year 12 Month 01 Day
Date of IRB	2015 Year 12 Month 01 Day
Anticipated trial start date	2015 Year 12 Month 15 Day
Last follow-up date	2020 Year 01 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	2015 Year 11 Month 30 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=R000023088