UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046764 |
|---|---|
| Receipt number | R000053338 |
| Scientific Title | A non-interventional, questionnaire-based study of doctors based on their experience with oligomeric formula of whey peptides containing dietary fiber |
| Date of disclosure of the study information | 2022/01/28 |
| Last modified on | 2023/09/26 14:19:49 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A non-interventional, questionnaire-based study of doctors based on their experience with oligomeric formula of whey peptides containing dietary fiber
Acronym
A non-interventional, questionnaire-based study of doctors based on their experience with oligomeric formula of whey peptides containing dietary fiber
Scientific Title
A non-interventional, questionnaire-based study of doctors based on their experience with oligomeric formula of whey peptides containing dietary fiber
Scientific Title:Acronym
A non-interventional, questionnaire-based study of doctors based on their experience with oligomeric formula of whey peptides containing dietary fiber
Region
| Japan |
Condition
Condition
Enteral feeding intolerance
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of the product by conducting a questionnaire survey of doctors who have experience using oligomeric formula of whey peptides containing dietary fiber (PEPTAMEN PREBIO) on patients.
Basic objectives2
Others
Basic objectives -Others
Not applicable
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Background of doctors who responded to the questionnaire of this study (type of hospital, number of beds, department)
2) Background of patients using PEPTAMEN PREBIO (sex, age, basal disease, concomitant drug, main method of nutritional management before using PEPTAMEN PREBIO)
3) Experience of using PEPTAMEN PREBIO
4) Reasons for using PEPTAMEN PREBIO
5) Reasons for discontinuation of use of PEPTAMEN PREBIO
6) Changes in the nutritional status of patients using PEPTAMEN PREBIO
7) Changes in diarrhea symptoms in patients using PEPTAMEN PREBIO
8) Components that contributed to the change of diarrhea after using PEPTAMEN PREBIO
9) Changes in reflux and vomiting symptoms in patients using PEPTAMEN PREBIO
10) Willingness to use PEPTAMEN PREBIO
11) Patients to be considered for use of PEPTAMEN PREBIO
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
Doctors who meet all of the following criteria at the time of enrollment in this study will be considered subjects of this study.
1) Doctors who understood the study and have given informed consent to participate in the study on the website
2) Doctors with experience in the use of PEPTAMEN PREBIO
3) Doctors who work at a medical institution that has inpatient beds with 24-hour emergency response capability
4) Doctors who is able to input 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 Health Science Company, 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
Institutional Review Board of Takahashi Clinic
Address
5-1-31 Iwayakita-machi, Nada-ku, Kobe City, Hyogo, Japan
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 | 01 | Month | 28 | Day |
Related information
URL releasing protocol
http://www.pieronline.jp/content/article/0386-3603/50110/1973
Publication of results
Published
Result
URL related to results and publications
http://www.pieronline.jp/content/article/0386-3603/50110/1973
Number of participants that the trial has enrolled
100
Results
Stated in the research paper
Results date posted
| 2023 | Year | 09 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Stated in the research paper
Participant flow
Stated in the research paper
Adverse events
Stated in the research paper
Outcome measures
Stated in the research paper
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 01 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 28 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, observational information will be collected via a web-based questionnaire.
The data to be collected is the information shown in the primary endpoints
Management information
Registered date
| 2022 | Year | 01 | Month | 28 | 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=R000053338
