UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041936 |
|---|---|
| Receipt number | 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 | 2021/09/29 15:56:41 |
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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
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
yamanakah@wakakoukai.or.jp
Sponsor or person
Institute
Wakakusa Daiichi Hospital
Institute
Department
Personal name
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
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
Completed
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 | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047853
