UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048410 |
|---|---|
| Receipt number | R000055173 |
| Scientific Title | A non-interventional, post-marketing survey study of healthcare professionals based on their experience using a high-fiber enteral feeding. |
| Date of disclosure of the study information | 2022/07/20 |
| Last modified on | 2023/09/26 14:10:48 |
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Basic information
Public title
A non-interventional, post-marketing survey study of healthcare professionals based on their experience using a high-fiber enteral feeding.
Acronym
A non-interventional, post-marketing survey study of healthcare professionals based on their experience using a high-fiber enteral feeding.
Scientific Title
A non-interventional, post-marketing survey study of healthcare professionals based on their experience using a high-fiber enteral feeding.
Scientific Title:Acronym
A non-interventional, post-marketing survey study of healthcare professionals based on their experience using a high-fiber enteral feeding.
Region
| Japan |
Condition
Condition
Constipation
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Conduct a survey of healthcare professionals who have experience using high fiber liquid diets (ISOCAL Fibecare) to evaluate the product for clinical use with patients.
Basic objectives2
Others
Basic objectives -Others
Not applicable
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Background of responding healthcare professionals
2) Background of patients using ISOCAL Fibecare
3) Experience with ISOCAL Fibecare
4) Changes in nutritional status of patients treated with ISOCAL Fibecare
5) Changes in defecation status of patients using ISOCAL Fibecare
6) Changes in constipation treatment in patients using ISOCAL Fibecare
7) Changes in complications in patients with ISOCAL Fibecare
8) Changes in defecation care status of patients with ISOCAL Fibecare
9) Intention to use ISOCAL Fibecare
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
At the time of enrollment, healthcare professionals who meet all of the following criteria will be considered research subjects
1) Physicians and nurses who fully understand the content of the study and have given their free and voluntary consent to participate in this study via the website.
2) Physicians and nurses who have used ISOCAL Fibecare for at least two weeks in patients with constipation symptoms (including patients with diarrhea caused by laxatives).
3) Physicians/nurses who can fill in and answer the questionnaire by themselves.
Key exclusion criteria
No setting
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yukikazu |
| Middle name | |
| Last name | Kamada |
Organization
Nestle Health Science Company, Nestle Japan Ltd.
Division name
Marketing & Medical Affairs
Zip code
140-0002
Address
2-2-20 Higashi-Shinagawa, Shinagawa-ku, Tokyo, Japan
TEL
03-5769-6227
Yukikazu.Kamada@jp.nestle.com
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Takano |
Organization
Nestle Health Science Company, Nestle Japan Ltd.
Division name
Marketing & Medical Affairs
Zip code
140-0002
Address
2-2-20 Higashi-Shinagawa, Shinagawa-ku, Tokyo, Japan
TEL
03-5769-6227
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
Takahashi Clinic Ethics Committee
Address
Medicalhat 1F , 5-1-31 ,kitamachi ,iwaya, nada-ku, kobe-shi, Hyogo
Tel
078-882-6432
kishimoto.satoshi@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
| 2022 | Year | 07 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S2667268523000463
Number of participants that the trial has enrolled
184
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
| 2022 | Year | 07 | Month | 11 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 21 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 01 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
not applicable
Management information
Registered date
| 2022 | Year | 07 | Month | 20 | Day |
Last modified on
| 2023 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055173
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
