UMIN-CTR Clinical Trial

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