UMIN-CTR Clinical Trial

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
Last 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
Email	dr-serita@michinoo.or.jp

Public contact
1st 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
Email	dr-serita@michinoo.or.jp

Sponsor
Institute	Michinoo hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041667