UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045641 |
|---|---|
| Receipt number | R000052105 |
| Scientific Title | Observational study of gut microbiota diversity in patients with long-term enteral nutrition |
| Date of disclosure of the study information | 2021/10/07 |
| Last modified on | 2021/10/02 14:20:59 |
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Basic information
Public title
Observational study of gut microbiota diversity in patients with long-term enteral nutrition
Acronym
Observational study of gut microbiota diversity in patients with long-term enteral nutrition
Scientific Title
Observational study of gut microbiota diversity in patients with long-term enteral nutrition
Scientific Title:Acronym
Observational study of gut microbiota diversity in patients with long-term enteral nutrition
Region
| Japan |
Condition
Condition
persistent vegetative state patients
Classification by specialty
| Hepato-biliary-pancreatic surgery | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether the diversity of the intestinal flora is reduced in patients with long-term bed rest and long-term enteral nutritional management due to persistent vegetative disorder compared to healthy subjects. In addition, the relationship between changes in the intestinal flora over time and changes in organic acids and bile acids in the body, changes in the level of consciousness disorder, susceptibility to infection, and changes in the level of consciousness disorder will be investigated.
Basic objectives2
Others
Basic objectives -Others
diversity of microbiota in persistent vegetative state patients
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
diversity of microbiota in persistent vegetative state patients
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who participated in this study and obtained written consent by the free will of their families after receiving sufficient explanation and with sufficient understanding.
Patients between the ages of 20 and 80 at the time of consent
Key exclusion criteria
Patients who are also taking antibiotics
In addition, patients who are judged to be inappropriate by the principal investigator and the research coordinator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | ISAO |
| Middle name | |
| Last name | MORITA |
Organization
Fujita Health University
Division name
neuro surgery
Zip code
4701192
Address
kutukake-cho dengakugakubo 1-98 Toyoake city Aichi Pref
TEL
0562932000
iokuma@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | HIROSHI |
| Middle name | |
| Last name | MATSUOKA |
Organization
Fujita Health University
Division name
gastroenterological surgery
Zip code
4701192
Address
kutukake-cho dengakugakubo 1-98 Toyoake city Aichi Pref
TEL
0562932000
Homepage URL
mats1025@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health Univ Hospital
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University neurosurgery
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fujita Health University IRB
Address
kutukake-cho dengakugakubo 1-98 Toyoake city Aichi Pref
Tel
0562932000
f-irb@fujita-hu.ac.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
| 2021 | Year | 10 | Month | 07 | 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
20
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 | 03 | Month | 31 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing
Management information
Registered date
| 2021 | Year | 10 | Month | 02 | Day |
Last modified on
| 2021 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052105
