UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041703 |
|---|---|
| Receipt number | R000047588 |
| Scientific Title | gastric emptying time of oligomeric formula in adult males - ultrasound assessment - |
| Date of disclosure of the study information | 2020/11/01 |
| Last modified on | 2023/05/03 13:26:40 |
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Basic information
Public title
gastric emptying time of oligomeric formula in adult males - ultrasound assessment -
Acronym
gastric emptying time of oligomeric formula in adult males - ultrasound assessment -
Scientific Title
gastric emptying time of oligomeric formula in adult males - ultrasound assessment -
Scientific Title:Acronym
gastric emptying time of oligomeric formula in adult males - ultrasound assessment -
Region
| Japan |
Condition
Condition
adult male
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will reveal the gastric emptying time of oligomeric formula in adult males using ultrasonography.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of cases in which the cross-sectional area of gastric antrum was less than or equal to 4.0 cm2 after oral intake of oligomeric formula or the cross-sectional area of gastric antrum was not less than or equal to 4.0 cm2 within 4 hours after oral intake of oligomeric formula.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Single oral intake of oligomeric formula
Interventions/Control_2
Single oral intake of sports drinks
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
| 75 | years-old | > |
Gender
Male
Key inclusion criteria
1)Aged 20 years or older and under 75 years old at the time of obtaining consent.
2)Male
3)Persons who have given the voluntary written consent to participate in this study,after receiving a sufficient explanation.
Key exclusion criteria
1)Persons with a history of serious gastrointestinal disease that require hospitalization or surgery.
2)Persons with a history of diabetes mellitus or those suspected of having an impaired glucose tolerance.
3)Students at Yamaguchi University
4)Persons with allergies to dairy products
5)Persons whom the principal investigator or assigned researcher judge unsuitable as a research subject.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Mishiya |
| Middle name | |
| Last name | Matsumoto |
Organization
Yamaguchi University Hospital
Division name
Department of Anesthesiology
Zip code
755-8505
Address
1-1-1 Minami Kogushi, Ube, Yamaguchi, Japan
TEL
0836-22-2291
mishiya@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Kiyotaka |
| Middle name | |
| Last name | Shiramoto |
Organization
Yamaguchi University Hospital
Division name
Intensive Care Unit
Zip code
755-8505
Address
1-1-1 Minami Kogushi, Ube, Yamaguchi, Japan
TEL
0836-22-2653
Homepage URL
k-shira@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University
Institute
Department
Personal name
Funding Source
Organization
Yamaguchi University Hospital
Department of Anesthesiology
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
Yamaguchi University Hospital Institutional Review Board
Address
1-1-1 Minami Kogushi, Ube, Yamaguchi, Japan
Tel
0836-22-2428
me223@yamaguchi-u.ac.jp
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
| 2020 | Year | 11 | 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
10
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
| 2020 | Year | 08 | Month | 26 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 26 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 06 | Day |
Last modified on
| 2023 | Year | 05 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047588
