UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025331 |
|---|---|
| Receipt number | 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 08:21:42 |
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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
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
tmishiro@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029140
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
