UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019998 |
|---|---|
| Receipt number | 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 | 2021/05/09 11:55:17 |
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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
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
sugimo@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023088
