UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059917 |
|---|---|
| Receipt number | R000068531 |
| Scientific Title | A Randomized Controlled Trial on the Safety and Efficacy of Jelly Drink Administration Before Upper Gastrointestinal Endoscopy |
| Date of disclosure of the study information | 2025/11/28 |
| Last modified on | 2025/11/28 18:22:44 |
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Basic information
Public title
A Randomized Controlled Trial on the Safety and Efficacy of Jelly Drink Administration Before Upper Gastrointestinal Endoscopy
Acronym
Randomized Controlled Trial on Jelly Drink Intake Before Upper Gastrointestinal Endoscopy
Scientific Title
A Randomized Controlled Trial on the Safety and Efficacy of Jelly Drink Administration Before Upper Gastrointestinal Endoscopy
Scientific Title:Acronym
Randomized Controlled Trial on Jelly Drink Intake Before Upper Gastrointestinal Endoscopy
Region
| Japan |
Condition
Condition
Individuals scheduled to undergo an upper gastrointestinal endoscopy
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
When an upper gastrointestinal endoscopy is scheduled, dietary restrictions apply from the evening before the procedure until the morning of the examination. A randomized trial will verify that consuming oral rehydration jelly allows the procedure to be performed safely, similar to conventional restrictions.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety of Upper Gastrointestinal Endoscopy
Key secondary outcomes
Vital signs before and after the examination (blood pressure, pulse rate, oxygen saturation), examination duration, level of hunger and stress prior to the examination, presence of any complications
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are 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
Oral Rehydration Jelly Intake
Interventions/Control_2
None
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Individuals aged 18 years or older who consent to participate in this study
2. Capable of oral intake
3. Individuals who, after receiving adequate explanation regarding participation in this trial, provided written consent based on full understanding and of their own free will
Key exclusion criteria
1. Individuals with sodium or potassium intake restrictions
2. Individuals with severe liver disease, kidney disease, heart disease, or other conditions that make participation in this study difficult
3. Individuals with severe pharyngeal or nasal cavity conditions preventing endoscope insertion
4. Individuals in poor general health
5. Individuals requiring emergency endoscopy
6. Individuals undergoing endoscopy for hemostasis purposes
7. Individuals unable to independently decide on trial participation
8. Individuals who understand the trial but do not consent to participate
9. Other individuals deemed unsuitable for this study by the attending physician
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Nagaike |
Organization
Suita Municipal Hospital
Division name
Endoscopy Center
Zip code
564-8567
Address
5-7,kishibesinmachi, suita-shi, Osaka
TEL
0663873311
nagaike.koji@gmail.com
Public contact
Name of contact person
| 1st name | koji |
| Middle name | |
| Last name | Nagaike |
Organization
Suita Municipal Hospital
Division name
Endoscopy Center
Zip code
564-8567
Address
5-7,kishibesinmachi, suita-shi, Osaka
TEL
0663873311
Homepage URL
nagaike.koji@gmail.com
Sponsor or person
Institute
Suita Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Suita Municipal Hospita Institutional Review Board
Address
5-7,kishibesinmachi, suita-shi, Osaka
Tel
0663873311
yakkyoku@mhp.suita.osaka.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
| 2025 | Year | 11 | Month | 28 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 06 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2026 | 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
| 2025 | Year | 11 | Month | 28 | Day |
Last modified on
| 2025 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068531
