UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000041936
Receipt No. R000047853
Scientific Title Clinical evaluation study on the safety of new liquid enteral nutrition formula.
Date of disclosure of the study information 2020/10/01
Last modified on 2021/04/01

* 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 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 yamanakah@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 yamanakah@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 No longer recruiting
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
2021 Year 04 Month 01 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


Contact us.