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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Patients requiring the nutritional management using tube feeding. | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |