UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060769 |
|---|---|
| Receipt number | R000069379 |
| Scientific Title | Post Marketing Survey of Healthcare Professionals Using a Viscosity Adjustable High Calorie Formula |
| Date of disclosure of the study information | 2026/02/27 |
| Last modified on | 2026/02/27 08:19:22 |
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Basic information
Public title
Post Marketing Survey of Healthcare Professionals Using a Viscosity Adjustable High Calorie Formula
Acronym
Post-Marketing Survey Study of a Viscosity-Adjustable High-Calorie Liquid Formula
Scientific Title
Post Marketing Survey of Healthcare Professionals Using a Viscosity Adjustable High Calorie Formula
Scientific Title:Acronym
Post-Marketing Survey Study of a Viscosity-Adjustable High-Calorie Liquid Formula
Region
| Japan |
Condition
Condition
Gastroesophageal reflux
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to assess the usefulness of a viscosity adjustable high calorie liquid formula through a questionnaire survey of healthcare professionals who have used it in patient care.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in Gastroesophageal Reflux Related Symptoms Before and After Use of a viscosity adjustable high calorie liquid formula
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Healthcare professionals who provided voluntary consent via the study website.
2. Healthcare professionals who have used a viscosity adjustable high calorie liquid formula in patients with gastroesophageal reflux symptoms.
3. Healthcare professionals who have obtained permission from the head of their medical institution to respond to the questionnaire.
3. Healthcare professionals who can independently complete the questionnaire.
Key exclusion criteria
None
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yukikazu |
| Middle name | |
| Last name | Kamada |
Organization
Nestle Japan Ltd
Division name
Nestle Health Science Company
Zip code
140-0002
Address
Tennozu Ocean Square 20F, 2-2-20 Higashi-Shinagawa, Shinagawa-ku, Tokyo
TEL
070-2278-7597
Yukikazu.Kamada@jp.nestle.com
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Takano |
Organization
Nestle Japan Ltd
Division name
Nestle Health Science Company
Zip code
140-0002
Address
Tennozu Ocean Square 20F, 2-2-20 Higashi-Shinagawa, Shinagawa-ku, Tokyo
TEL
070-2448-5234
Homepage URL
Hiroki.takano@jp.nestle.com
Sponsor or person
Institute
Nestle Health Science Company, Nestle Japan Ltd.
Institute
Department
Personal name
Funding Source
Organization
Nestle Japan Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo.
Tel
03-5408-1599
shiba_palace@s-palace-clinic.com
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
| 2026 | Year | 02 | Month | 27 | 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
| 2026 | Year | 02 | Month | 24 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 26 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 27 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2026 | Year | 02 | Month | 27 | Day |
Last modified on
| 2026 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069379
