UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032040 |
|---|---|
| Receipt number | R000036556 |
| Scientific Title | The exploratory study on change of the gutmicrobiota in Rabeprazole divided doses:Direction crossover controlled trial in front of an open label |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2021/05/09 11:57:20 |
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Basic information
Public title
The exploratory study on change of the gutmicrobiota in Rabeprazole divided doses:Direction crossover controlled trial in front of an open label
Acronym
The exploratory study on change of the gutmicrobiota in the Rabeprazole administration
Scientific Title
The exploratory study on change of the gutmicrobiota in Rabeprazole divided doses:Direction crossover controlled trial in front of an open label
Scientific Title:Acronym
The exploratory study on change of the gutmicrobiota in the Rabeprazole administration
Region
| Japan |
Condition
Condition
Reflux esophagitis.
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to determine the association between intragastric pH and change of the intestinal bacterial flora by changing the proton pump inhibitor doses.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation of intragastric pH and enteric bacteria profile.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Subjects are 12 Helicobacter pylori infection-negative healthy Volunteers.Subjects take rabeprazole 10 mg o.d for 7 days. We conduct examination of 24 hours pH monitoring and flora sampling on the seventh day.
Interventions/Control_2
Subjects are 12 Helicobacter pylori infection-negative healthy Volunteers.Subjects take rabeprazole 5mg o.d for 7 days. We conduct examination of 24 hours pH monitoring and flora sampling on the seventh day.
Interventions/Control_3
Subjects are 12 Helicobacter pylori infection-negative healthy Volunteers.Subjects take rabeprazole 5mg bid for 7 days. We conduct examination of 24 hours pH monitoring and flora sampling on the seventh day.
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.With consent
2.From 20 years old to 50 years old.
2.H.pylori infection-negative.
3.Performance status:ECOG 0.
Key exclusion criteria
1.No consent
2.With the drug including a suppressant acid-secreting for the past one month.
3.With probiotics (medicine for intestinal disorders) or the antimicrobial agent for the past one month.
4.With grapefruits for the past two weeks.
5.With operating treatment for upper gastrointestinal disease including esophagus and stomach.
6.During pregnancy or nursing.
Target sample size
12
Research contact person
Name of lead principal investigator
| 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, JAPAN,520-2192
TEL
077-548-2618
sugimo@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, JAPAN,520-2192
TEL
077-548-2618
Homepage URL
sugimo@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
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
| 2018 | Year | 04 | Month | 01 | 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
| 2018 | Year | 03 | Month | 29 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 29 | Day |
Last follow-up date
| 2019 | Year | 03 | 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
| 2018 | Year | 03 | Month | 31 | 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=R000036556
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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