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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000019998
Receipt No. R000023088
Scientific Title Change of microbiota of oral cavity, stomach and intestine by administration of lansoprazole and vonoprazan
Date of disclosure of the study information 2015/12/15
Last modified on 2015/12/21

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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 Open public recruiting
Date of protocol fixation
2015 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 15 Day
Last follow-up date
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
2015 Year 12 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023088

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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