UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061366 |
|---|---|
| Receipt number | R000070210 |
| Scientific Title | Clinical Assessment of Nutritional Therapy Awareness, Practice, and Collaboration for Liver Cirrhosis: An Internet Survey |
| Date of disclosure of the study information | 2026/04/28 |
| Last modified on | 2026/04/27 10:25:21 |
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Basic information
Public title
Clinical Assessment of Nutritional Therapy Awareness, Practice, and Collaboration for Liver Cirrhosis: An Internet Survey
Acronym
Clinical Assessment of Nutritional Therapy Awareness, Practice, and Collaboration for Liver Cirrhosis: An Internet Survey
Scientific Title
Clinical Assessment of Nutritional Therapy Awareness, Practice, and Collaboration for Liver Cirrhosis: An Internet Survey
Scientific Title:Acronym
Clinical Assessment of Nutritional Therapy Awareness, Practice, and Collaboration for Liver Cirrhosis: An Internet Survey
Region
| Japan |
Condition
Condition
Cirrhosis
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Surgery in general |
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To conduct a web-based questionnaire survey of physicians who routinely manage patients with liver cirrhosis, with the aim of clarifying the current status of nutritional therapy for liver cirrhosis.
Basic objectives2
Others
Basic objectives -Others
To describe physicians' awareness and current practices of nutritional therapy for liver cirrhosis, including nutritional assessment, sarcopenia assessment, dietary management, prescribing practices, and nutritional management systems in routine clinical care.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The following items will be explored descriptively in this survey.
1. Clinical backgrounds of respondents and routine clinical practice for liver cirrhosis
2. Awareness of nutritional therapy and relevant clinical guidelines
3. Current practices of nutritional and sarcopenia assessments
4. Current practices of dietary therapy, including divided meals and late evening snack (LES)
5. Prescribing practices of BCAA granules and enteral nutritional formulas for hepatic failure
6. Status of nutritional management systems and collaboration with dietitians
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
Physicians registered with the survey panel managed by Cross Marketing Inc. who have provided informed consent to participate in this survey. In addition, eligible participants are physicians who routinely manage patients with liver cirrhosis in their daily clinical practice.
Key exclusion criteria
None
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Sayaka |
| Middle name | |
| Last name | Kudo |
Organization
EA Pharma Co., Ltd.
Division name
Medical Science Group, Medical Dept.
Zip code
104-0042
Address
Sumitomo Irifune Building, 2-1-1 Irifune, Chuo-ku, Tokyo 104-0042, Japan
TEL
070-3183-3343
sayaka_kudo@eapharma.co.jp
Public contact
Name of contact person
| 1st name | Sayaka |
| Middle name | |
| Last name | Kudo |
Organization
EA Pharma Co., Ltd.
Division name
Medical Science Group, Medical Dept.
Zip code
104-0042
Address
Sumitomo Irifune Building, 2-1-1 Irifune, Chuo-ku, Tokyo 104-0042, Japan
TEL
070-3183-3343
Homepage URL
sayaka_kudo@eapharma.co.jp
Sponsor or person
Institute
EA Pharma Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
EA Pharma Co., Ltd.
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
Yamauchi Clinic Research Ethics Committee
Address
1-15-9 Jiyugaoka, Meguro-ku, Tokyo
Tel
03-6777-1490
c-irb_ug@neues.co.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
| 2026 | Year | 04 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 17 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 17 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 19 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is an observational, web-based questionnaire survey designed to descriptively and exploratorily characterize current practices related to nutritional therapy for liver cirrhosis, including physicians' awareness, assessment methods, prescribing practices, and nutritional management systems. This study does not aim to evaluate the effectiveness of any intervention but to describe routine clinical practice.
Management information
Registered date
| 2026 | Year | 04 | Month | 24 | Day |
Last modified on
| 2026 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070210
