UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024048 |
|---|---|
| Receipt number | R000027532 |
| Scientific Title | The effects on gut microbiome by taking protom pump inhibitor in the patients with gastroesophageal reflux disease |
| Date of disclosure of the study information | 2016/09/15 |
| Last modified on | 2018/01/30 21:05:35 |
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Basic information
Public title
The effects on gut microbiome by taking protom pump inhibitor in the patients with gastroesophageal reflux disease
Acronym
proton pmp inhibitor and gut microbiome
Scientific Title
The effects on gut microbiome by taking protom pump inhibitor in the patients with gastroesophageal reflux disease
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Akiko Shiotani |
Organization
Kawasaki Medical School
Division name
Gastroenterology
Zip code
Address
577 Matsusima, Kurashiki city, Okayama, Japan
TEL
086-462-1111
shiotani@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akiko Shiotani |
Organization
Kawasaki Medical School
Division name
Gastroenterology
Zip code
Address
577 Matsusima, Kurashiki city, Okayama, Japan
TEL
086-462-1111
Homepage URL
shiotani@med.kawasaki-m.ac.jp
Sponsor or person
Institute
kawasaki Medical School
Institute
Department
Personal name
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)
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
| 2016 | Year | 09 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 07 | Month | 27 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027532
