UMIN-CTR Clinical Trial

Basic information
Public title	Clinical evaluation study on the safety of new liquid enteral nutrition formula.
Acronym	Clinical evaluation study of new liquid enteral nutrition formula.
Scientific Title	Clinical evaluation study on the safety of new liquid enteral nutrition formula.
Scientific Title:Acronym	Clinical evaluation study of new liquid enteral nutrition formula.
Region	Japan

Condition
Condition	Patients requiring the nutritional management using tube feeding.
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	For patients who received the new liquid enteral nutrition formula, clinical symptoms after administration will be examined and clinical evaluation will be performed.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Nutrition management completion rate
Key secondary outcomes

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 new liquid enteral nutrition formula for 7 to 28 days.
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) Patients with nasal tube feeding and gastrostomy tube feeding indication. 2) Patients in hospital. 3) Patients with the consent of the patient or his / her substitute. 4) Patients over 20 years old at the time of consent. 5) Patients with the tip of a tube feeding catheter placed in the stomach.
Key exclusion criteria	1) Patients who may have food allergies or allergic reactions to the products used in this study. 2) Patients with severe diarrhea within a week before the start of administration of the new liquid enteral nutrition formula. 3) Patients with gastroesophageal reflux. 4) Patients with ileus. 5) Patients who have difficulty in participating in this study due to complications such as liver disorder, renal disorder, and heart disease. 6) Patients who are pregnant and breastfeeding, or who may be pregnant. 7) Patients who judged not to be appropriate for study by the medical attendant.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Hideharu Middle name Last name Yamanaka
Organization	Wakakusa Daiichi Hospital
Division name	Surgery
Zip code	579-8056
Address	1-6 Wakakusa-cho, Higashi-Osaka City, Osaka, Japan
TEL	072-988-1409
Email	wakakusa@wakakoukai.or.jp

Public contact
Name of contact person	1st name Hideharu Middle name Last name Yamanaka
Organization	Wakakusa Daiichi Hospital
Division name	Surgery
Zip code	579-8056
Address	1-6 Wakakusa-cho, Higashi-Osaka City, Osaka, Japan
TEL	072-988-1409
Homepage URL
Email	wakakusa@wakakoukai.or.jp

Sponsor
Institute	Wakakusa Daiichi Hospital
Institute
Department

Funding Source
Organization	NUTRI 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	The Ethics Committee of Wakakusa Daiichi Hospital
Address	1-6 Wakakusa-cho, Higashi-Osaka City, Osaka, Japan
Tel	072-988-1409
Email	wakakusa@wakakoukai.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	2020 Year 10 Month 01 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	Enrolling by invitation
Date of protocol fixation	2020 Year 09 Month 24 Day
Date of IRB	2020 Year 09 Month 14 Day
Anticipated trial start date	2020 Year 10 Month 01 Day
Last follow-up date	2021 Year 03 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	2020 Year 09 Month 29 Day
Last modified on	2020 Year 11 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047853

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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