UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045606 |
|---|---|
| Receipt number | R000052057 |
| Scientific Title | A clinical study to evaluate the nutritional management for the patients receiving tube feeding with an enteral nutrition formula, EDPAC-01 |
| Date of disclosure of the study information | 2021/09/30 |
| Last modified on | 2022/04/01 11:31:09 |
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Basic information
Public title
A clinical study to evaluate the nutritional management for the patients receiving tube feeding with an enteral nutrition formula, EDPAC-01
Acronym
A clinical study to evaluate the nutritional management with an enteral nutrition formula, EDPAC-01
Scientific Title
A clinical study to evaluate the nutritional management for the patients receiving tube feeding with an enteral nutrition formula, EDPAC-01
Scientific Title:Acronym
A clinical study to evaluate the nutritional management with an enteral nutrition formula, EDPAC-01
Region
| Japan |
Condition
Condition
Patients receiving enteral tube feeding
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate nutritional management with the test food
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body weight
Key secondary outcomes
Nutritional status (levels of pre-albumin and albumin), defecation status (number of times and fecality), gastrointestinal symptoms (number of vomiting and diarrhea), fever days
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Administer the test food for 4 weeks
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Subjects with the age of 20 or more
2. Subjects getting all nutrition by tube feeding through nasal, gastrostomy, or intestinal fistula
3. Subjects expected to continue the tube feeding more than 1 month
Key exclusion criteria
1. Subjects having serious diseases on organs such as liver, kidney, heart, lung, and digestive tract, and systems in blood, endocrine, and metabolism.
2. Subjects having diabetes with the HbA1c value 8% or more
3. Subjects having a history with drug allergy or serious food allergy
4. Subjects participating in another clinical study about drug, food, and so on.
5. Subjects with unstable energy doses for the last month
6. Subjects judged to be inappropriate for the study by the investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tomihiro |
| Middle name | |
| Last name | Kawamitsu |
Organization
Sangenjaya Hospital
Division name
Sangenjaya Hospital
Zip code
154-0024
Address
1-21-5, Sangenjaya, Setagaya-Ku, Tokyo, Japan
TEL
03-3410-7321
sangenjaya-hp@hotmail.co.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Matsubara |
Organization
Morinaga Milk Industry Co., Ltd.
Division name
Health Care & Nutritional Science Institute, R&D Division
Zip code
252-8583
Address
1-83, 5-Chome, Higashihara, Zama-City, Kanagawa-Pref, Japan
TEL
046-252-3057
Homepage URL
ta-matsubara@morinagamilk.co.jp
Sponsor or person
Institute
Sangenjaya Hospital
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry Co., 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
Sangenjaya Hospital Institutional Review Board
Address
1-21-5, Sangenjaya, Setagaya-Ku, Tokyo, Japan
Tel
03-3410-7321
sangenjaya-hp@hotmail.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
医療法人社団大坪会三軒茶屋病院（東京都）/Sangenjaya Hospital (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 30 | 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
Completed
Date of protocol fixation
| 2021 | Year | 08 | Month | 02 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 03 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2022 | Year | 03 | Month | 17 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
This clinical study will be performed in parallel with another facility (UMIN000045544)
Management information
Registered date
| 2021 | Year | 09 | Month | 29 | Day |
Last modified on
| 2022 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052057
