UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020333 |
|---|---|
| Receipt number | R000023480 |
| Scientific Title | Effect of carbonated water administration on gastric emptying |
| Date of disclosure of the study information | 2015/12/25 |
| Last modified on | 2020/06/27 21:16:17 |
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Basic information
Public title
Effect of carbonated water administration on gastric emptying
Acronym
Effect of carbonated water administration on gastric emptying
Scientific Title
Effect of carbonated water administration on gastric emptying
Scientific Title:Acronym
Effect of carbonated water administration on gastric emptying
Region
| Japan |
Condition
Condition
Functional gastrointestinal disorders
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Carbonated water has been considered capable of relieving gastrointestinal symptoms.The aim of this study was to determine that single pre-prandial carbonated water administration might have an effect on the rate of liquid and solid gastric emptying using the 13C-acetic acid breath test.
Basic objectives2
Others
Basic objectives -Others
Effect of carbonated water on the rate of liquid and solid gastric emptying
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The measuring of the rate of gastric emptying using a 13C breath test
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
carbonated water
Interventions/Control_2
water
Interventions/Control_3
sham
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
Healthy adult
Key exclusion criteria
Medication, history of abdominal surgery
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiko Inamori |
Organization
Yokohama City University Hospital
Division name
Office of Postgraduate Medical Education
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2976
inamorim@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi iida |
Organization
Yokohama City University School of Medicine
Division name
Department of Medical Education
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2626
Homepage URL
hiro0905@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Hospital Office of Postgraduate Medical Education
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
| 2015 | Year | 12 | Month | 25 | 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
| 2015 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 24 | Day |
Last modified on
| 2020 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023480
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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