UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053602 |
|---|---|
| Receipt number | R000061167 |
| Scientific Title | Research on the effects of different administered liquid diets on the nutritional status and Fecal characteristics of tube feeding patients. |
| Date of disclosure of the study information | 2024/02/13 |
| Last modified on | 2025/03/28 11:47:19 |
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Basic information
Public title
Research on the effects of different administered liquid diets on the nutritional status and Fecal characteristics of tube feeding patients.
Acronym
Research on the effects of different administered liquid diets on the nutritional status and Fecal characteristics of tube feeding patients.
Scientific Title
Research on the effects of different administered liquid diets on the nutritional status and Fecal characteristics of tube feeding patients.
Scientific Title:Acronym
Research on the effects of different administered liquid diets on the nutritional status and Fecal characteristics of tube feeding patients.
Region
| Japan |
Condition
Condition
Patients receiving enteral tube feeding
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will conduct a retrospective observational study in tube feeding patients.
To evaluate the effects of a new liquid enteral formula containing ingredients fermented by lactic acid bacteria ingredients on nutritional status and fecal characteristics.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Alb, T-cho, BMI, Body weight, GNRI, Fecal characteristics, Stool frequency, The number of defecation days, Fecal color, Disimpaction frequency, Use of medications or foods related to defecation control
Key secondary outcomes
BUN, Cre, BUN/Cre, eGFR, The number of febrile days, The number of exacerbation days
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who have been on tube feeding for more than 4 weeks as of February 2024.
2) Patients who have been on a general liquid enteral formula or a new liquid enteral formula containing ingredients fermented by lactic acid bacteria for more than 4 weeks as of February 2024.
3) Patients who obtained informed consents.
Key exclusion criteria
Patients who judged by the principal investigator to be inappropriate as participants in this test.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Motoyoshi |
| Middle name | |
| Last name | Yamazaki |
Organization
Ojiya Sakura Hospital
Division name
-
Zip code
947-0041
Address
2732, Kowada, Ojiya City, Niigata, 947-0041, Japan
TEL
0258-83-2680
yamazaki@sakurahp.com
Public contact
Name of contact person
| 1st name | Motoyoshi |
| Middle name | |
| Last name | Yamazaki |
Organization
Ojiya Sakura Hospital
Division name
-
Zip code
947-0041
Address
2732, Kowada, Ojiya City, Niigata, 947-0041, Japan
TEL
0258-83-2680
Homepage URL
yamazaki@sakurahp.com
Sponsor or person
Institute
Ojiya Sakura Hospital
Institute
Department
Personal name
Funding Source
Organization
Meiji Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Meiji Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Meiji Institutional Review Board
Address
1-29-1 Nanakuni, Hachiouji, Tokyo 192-0919, Japan
Tel
042-632-5900
MEIJI.IRB@meiji.com
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
社会福祉法人 長岡福祉協会 小千谷さくら病院（新潟県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 13 | 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
| 2024 | Year | 01 | Month | 29 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 13 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2025 | Year | 02 | Month | 28 | Day |
Other
Other related information
We will conduct a retrospective observational study in tube feeding patients.
To evaluate the effects of a new liquid enteral formula containing ingredients fermented by lactic acid bacteria ingredients on nutritional status and fecal characteristics.
Management information
Registered date
| 2024 | Year | 02 | Month | 13 | Day |
Last modified on
| 2025 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061167
