UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060172 |
|---|---|
| Receipt number | R000068735 |
| Scientific Title | The inhibitory effect of NVIF2025-02 intake on diarrhea symptoms |
| Date of disclosure of the study information | 2026/01/06 |
| Last modified on | 2025/12/19 11:29:41 |
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Basic information
Public title
The inhibitory effect of NVIF2025-02 intake on diarrhea symptoms
Acronym
The inhibitory effect of NVIF2025-02 intake on diarrhea symptoms
Scientific Title
The inhibitory effect of NVIF2025-02 intake on diarrhea symptoms
Scientific Title:Acronym
The inhibitory effect of NVIF2025-02 intake on diarrhea symptoms
Region
| Japan |
Condition
Condition
Patients receiving enteral nutrition due to difficulty with oral intake or poor nutritional status.
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the efficacy of NVIF2025-2 in alleviating diarrhea symptoms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Defecation frequency
Bristol Stool Form Scale
Dermal frailty assessment checklist
Stratum corneum hydration level
Transepidermal water loss
Key secondary outcomes
Fecal gut microbiota composition
Fecal short-chain fatty acid (SCFA) concentrations
Fecal putrefactive metabolites
Fecal pH value
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Base Enteral nutrition formula (1 week ingestion) -> Base Enteral nutrition formula containing NVIF-02. (4 weeks ingestion)
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
| 65 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Hospitalized patients receiving enteral nutrition due to poor oral intake or malnutrition
Key exclusion criteria
Patients with complications, e.g., pancreatic fistula (post-pancreaticoduodenectomy)
Patients scheduled to receive total parenteral nutrition (TPN)
Patients with clinically significant infections
Patients with respiratory failure
Patients receiving antimicrobial agents
Patients with an estimated glomerular filtration rate (eGFR) of stage 4 or lower
Patients with severe hepatic dysfunction (e.g., marked jaundice, ascites, or edema)
Patients with uncontrolled diabetes mellitus
Patients with known allergies to components of the investigational food
Patients with a history of hypersensitivity to components of the investigational food
Other patients deemed unsuitable by the principal investigator
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Mizuno |
Organization
Mejiro Daini Hospital, Etsudenkai Medical Corporation
Division name
Surgery
Zip code
1970011
Address
1980 Fussa, Fussa City, Tokyo, Japan
TEL
042-553-3511
zbm05143.sky@orange.zero.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Takahashi |
Organization
Nagase Viita Co., Ltd.
Division name
Research, Technology and Value Creation Division, Product Value Creation Department
Zip code
7028006
Address
675-1 Fujisaki, Naka Ward, Okayama City, Okayama Prefecture, Japan
TEL
0862763141
Homepage URL
jun.takahashi@nagase.co.jp
Sponsor or person
Institute
Mejiro Daini Hospital, Etsudenkai Medical Corporation
Institute
Department
Personal name
Funding Source
Organization
Nagase Viita 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
Etsudenkai Medical Corporation Mejiro Daini Hospital Ethics Committee
Address
1980 Fussa, Fussa City, Tokyo, Japan
Tel
042-553-3511
mejiro_hp_gyomu@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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 06 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 12 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 12 | 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
| 2025 | Year | 12 | Month | 23 | Day |
Last modified on
| 2025 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068735
