UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036569 |
|---|---|
| Receipt number | R000041667 |
| Scientific Title | An exploratory study to evaluate the efficacy of novel enteral nutrition VVT-01 for nasal tube feeding patients |
| Date of disclosure of the study information | 2019/04/22 |
| Last modified on | 2019/04/22 09:29:27 |
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Basic information
Public title
An exploratory study to evaluate the efficacy of novel enteral nutrition VVT-01 for nasal tube feeding patients
Acronym
An exploratory study to evaluate the efficacy of novel enteral nutrition VVT-01
Scientific Title
An exploratory study to evaluate the efficacy of novel enteral nutrition VVT-01 for nasal tube feeding patients
Scientific Title:Acronym
An exploratory study to evaluate the efficacy of novel enteral nutrition VVT-01
Region
| Japan |
Condition
Condition
nasal tube feeding patients
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To observe the effect of novel enteral nutrition VVT-01 on nutritional condition, fever symptoms, digestive symptoms such as diarrhea, vomiting.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
body weight
Key secondary outcomes
Digestive symptoms (diarrhea and vomiting frequency), defecation situation (defecation frequency and fecal condition), fever frequency, nutritional condition (serum albumin)
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
Administered novel enteral nutrition VVT-01 for 12 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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Subjects who receive transnasal nutrition.
2. Subjects who are 50 years or older.
3. Subjects who have an expectation to continue transnasal nutrition more than 1 month.
Key exclusion criteria
1. Subjects who have serious disease such as liver, kidney, heart, lung, digestive, hematological and metabolic.
2. Subjects who have history of drug or serious food allergy.
3. Subjects who are participate in the other study about drug during the study period.
4. Subjects whose energy doses are not stable for the last 1 month.
5. Subjects judged inappropriate for the study by the investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takumi |
| Middle name | |
| Last name | Serita |
Organization
Michinoo hospital
Division name
Psychiatry
Zip code
852-8055
Address
1-1, Nijigaoka, Nagasaki, Nagasaki, Japan
TEL
095-856-1111
dr-serita@michinoo.or.jp
Public contact
Name of contact person
| 1st name | Takumi |
| Middle name | |
| Last name | Serita |
Organization
Michinoo hospital
Division name
Psychiatry
Zip code
852-8055
Address
1-1, Nijigaoka, Nagasaki, Nagasaki, Japan
TEL
095-856-1111
Homepage URL
dr-serita@michinoo.or.jp
Sponsor or person
Institute
Michinoo hospital
Institute
Department
Personal name
Funding Source
Organization
MORINAGA MILK INDUSTRY CO.
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
Michinoo hospital IRB
Address
1-1, Nijigaoka, Nagasaki, Nagasaki, Japan
Tel
095-856-1111
dr-serita@michinoo.or.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
| 2019 | Year | 04 | Month | 22 | 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
| 2019 | Year | 03 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 04 | Month | 22 | Day |
Last modified on
| 2019 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041667
