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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000045641
Receipt No. 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

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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
Email 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
Email mats1025@fujita-hu.ac.jp

Sponsor
Institute Fujita Health Univ Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052105

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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