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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000025331
Receipt No. R000029140
Scientific Title Research on the effect of a proton pump inhibitor on the oral and intestinal microbiota and salivary protein and metabolites.
Date of disclosure of the study information 2016/12/20
Last modified on 2016/12/20

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Basic information
Public title Research on the effect of a proton pump inhibitor on the oral and intestinal microbiota and salivary protein and metabolites.
Acronym Influence of PPI on oral microbiota
Scientific Title Research on the effect of a proton pump inhibitor on the oral and intestinal microbiota and salivary protein and metabolites.
Scientific Title:Acronym Influence of PPI on oral microbiota
Region
Japan

Condition
Condition healthy volunteer
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of the present study was to explore the influence of PPI usage on the oral and gut microbiota with healthy volunteers.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Ten adult healthy volunteers with no medications donated the fecal, saliva and periodontal pocket fluid samples before and after administration of esomeprazole 20mg once daily for 4 weeks. We then investigate the effect of PPIs on the bacterial communities using 16S rRNA gene sequencing method.
Key secondary outcomes

Base
Study type Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1) over 20 year old
2) Informed consent about this research has been obtained with participants in writing form.
Key exclusion criteria 1) daily usage of steroids, immunosuppresive and anticancer drugs
2) 20 or fewer teeth
3) using antibiotics during use or within 1 month
4) During pregnancy, lactating, a woman who may be pregnant
5) history of allergy to esomeprazole
6) A case of a history of resection of the gastrointestinal tract except for appendectomy
7) the research director judged inappropriate as the subject of this research
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsuyoshi Mishiro
Organization Shimane university school of medicine
Division name Division of gastroenterology
Zip code
Address 89-1 Enya-cho, Izumo, Shimane, Japan
TEL 0853-20-2190
Email tmishiro@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tsuyoshi Mishiro
Organization Shimane university school of medicine
Division name Division of gastroenterology
Zip code
Address 89-1 Enya-cho, Izumo, Shimane, Japan
TEL 0853-20-2190
Homepage URL
Email tmishiro@med.shimane-u.ac.jp

Sponsor
Institute Shimane university
Institute
Department

Funding Source
Organization self funding
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
2016 Year 12 Month 20 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
Date of protocol fixation
2015 Year 12 Month 02 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Ten adult healthy volunteers with no medications donated the fecal, saliva and periodontal pocket fluid samples before and after administration of esomeprazole 20mg once daily for 4 weeks. We then investigate the effect of PPIs on the bacterial communities using 16S rRNA gene sequencing method.

Management information
Registered date
2016 Year 12 Month 20 Day
Last modified on
2016 Year 12 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029140

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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