UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050412 |
|---|---|
| Receipt number | R000057265 |
| Scientific Title | Nutrient drinking test for gastric accommodation |
| Date of disclosure of the study information | 2023/02/22 |
| Last modified on | 2023/08/24 10:40:16 |
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Basic information
Public title
Nutrient drinking test for gastric accommodation
Acronym
Nutrient drinking test for gastric accommodation
Scientific Title
Nutrient drinking test for gastric accommodation
Scientific Title:Acronym
Nutrient drinking test for gastric accommodation
Region
| Japan |
Condition
Condition
Functional dyspepsia
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the relationship between gastrointestinal symptoms (gastric and duodenal symptoms) and gastric dysfunction associated with functional diseases.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time required and amount consumed before bloating or epigastric symptoms due to liquid diet load make continuation impossible
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
After fasting overnight, a pump is used to supply 1.5 kcal/ml of the digestive-form nutritional liquid diet Peptamen Standard in one of two cups in a beaker at 15 ml/min, and when the subject picks up one cup, he or she begins to fill the other cup. In this way, the subjects drink the liquid diet continuously, and every 5 minutes, using an evaluation sheet, they are asked to rate their sensations related to eating (hunger, whether they can still eat, feeling full and unable to eat = satiety) and upper abdominal symptoms (stomach upset, lethargy, nausea, caps, feeling of stomach cramps, epicardial pain) on the 10 cm Visual Analogue Scale (VAS) will be used to assess The study will be terminated if bloating makes it impossible to continue the study, but the maximum duration of the study will be 50 minutes. During the study, the remaining portion of the test meal should not be visible to the subject. During the liquid diet loading test, electrocardiographic waveforms will be measured using a heart rate variability measuring device (Croswell). Two seal-type electrodes will be placed on the chest for heart rate variability.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients suspected of having a functional gastrointestinal disorder based on symptoms and physical findings, and faculty members and undergraduate students of Keio University School of Medicine, all of whom are at least 18 years old, will be included in the study to establish reference values for healthy subjects.
Key exclusion criteria
Patients with daily symptoms of aspiration due to drinking or eating, those with allergies to milk or soy, and other patients who are deemed inappropriate for inclusion in the study by the physician in charge or others.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Takanori |
| Middle name | |
| Last name | Kanai |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0333531211
takagast@z2.keio.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Mori |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0333531211
Homepage URL
koyamaru2002@yahoo.co.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Hideki Mori
Funding Source
Organization
Sekf funded
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
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, SHinjuku-ku, Tokyo
Tel
0333531211
med-rinri-jimu@adst.keio.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
| 2023 | Year | 02 | Month | 22 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 21 | Day |
Last follow-up date
| 2028 | Year | 12 | 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
| 2023 | Year | 02 | Month | 22 | Day |
Last modified on
| 2023 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057265
