UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Research on the effect of a proton pump inhibitor on the oral and intestinal microbiota and salivary protein and metabolites.
Title of the study (Brief title)	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	Tsuyoshi Mishiro
Organization	Shimane university school of medicine
Division name	Division of gastroenterology
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	Tsuyoshi Mishiro
Organization	Shimane university school of medicine
Division name	Division of gastroenterology
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)

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

Progress
Recruitment status	Recruiting
Date of protocol fixation	2015 Year 12 Month 02 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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