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

* 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

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

Email

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


Email

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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041667


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name