UMIN-CTR Clinical Trial

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
Email	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
Email	ta-matsubara@morinagamilk.co.jp

Sponsor
Institute	Sangenjaya Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052057