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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041254
Receipt No. R000047086
Scientific Title Oral and gut microbiota composition in patients with percutaneous endoscopic gastrostomy
Date of disclosure of the study information 2020/07/30
Last modified on 2020/07/30

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Basic information
Public title Microbiota in patients with gastrostomy
Acronym Microbiota and gastrostomy
Scientific Title Oral and gut microbiota composition in patients with percutaneous endoscopic gastrostomy
Scientific Title:Acronym Oral and gut microbiota and percutaneous endoscopic gastrostomy
Region
Japan

Condition
Condition patients with percutaneous endoscopic gastrostomy
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Pneumology Neurology Geriatrics
Surgery in general Gastrointestinal surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aimed to clarify the characteristics of microbiota who underwent percutaneous endoscopic gastrostomy by analyzing the oral and gut microbiota composition using metagenomic analysis.
Basic objectives2 Others
Basic objectives -Others To investigate the relationship between the microbiota and the short-term mortality and complications after gastrostomy, and long-term nutritional improvement.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Characteristics of microbiota in patients who underwent percutaneous endoscopic gastrostomy.
Key secondary outcomes 1) Changes in microbiota before and after gastrostomy
2) Relationship between microbiota and complications in gastrostomy patients, and short-term death (within 30 days) after gastrostomy
3) Relationship between changes in nutritional index (GNRI, PNI, O-PNI), frailty index, blood test data, CT values of L3-SMI and gut microbiota approximately 6 months after gastrostomy
4) Concordance rate of gastric microbiota between gastric juice suctioned endoscopically and suctioned using PEG tube.

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 Patients planed to have a percutaneous endoscopic gastrostomy
Key exclusion criteria 1) Patients without informed consent
2) Patients who had received antibiotic therapy within one month before gastrostomy
3) Patients with advanced pharyngeal cancer or esophageal cancer
4) Patients after gastrectomy or colectomy
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Shingo
Middle name
Last name Ono
Organization The Jikei University School of Medicine
Division name Endoscopy
Zip code 105-8471
Address 3-19-18 Nishi-shimbashi, Minato-ku, Tokyo, Japan
TEL 03-3433-1111
Email onoshingo@jikei.ac.jp

Public contact
Name of contact person
1st name Shingo
Middle name
Last name Ono
Organization The Jikei University School of Medicine
Division name Endoscopy
Zip code 105-8471
Address 3-19-18 Nishi-shimbashi, Minato-ku, Tokyo, Japan
TEL 03-3433-1111
Homepage URL
Email onoshingo@jikei.ac.jp

Sponsor
Institute The Jikei University School of Medicine
Institute
Department

Funding Source
Organization The Uehara Memorial Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor Institute of Physical and Chemical Research(RIKEN), International University of Health and Welfare (IUWH)
Name of secondary funder(s)

IRB Contact (For public release)
Organization The Jikei University School of Medicine
Address 3-19-18 Nishi-shimbashi, Minato-ku, Tokyo, Japan
Tel 0334331111
Email onoshingo@jikei.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
2020 Year 07 Month 30 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 Open public recruiting
Date of protocol fixation
2020 Year 01 Month 11 Day
Date of IRB
2020 Year 04 Month 14 Day
Anticipated trial start date
2020 Year 04 Month 14 Day
Last follow-up date
2022 Year 10 Month 13 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The aim of this study is to clarify the characteristics of microbiota who underwent gastrostomy by analyzing the oral and gut microbiota composition using metagenomic analysis.
We will analyze the relationship between microbiota at the baseline and complications (pneumoniae, peritonitis, fistulitis, etc.) in gastrostomy patients, and short-term death (within 30 days) after gastrostomy.
We will analyze the gut microbiota profile in the baseline of patients who underwent gastrostomy with nutritional improvement after six months, and search the microbiota highly associated with improved nutritional index (GNRI, PNI, CONUT, etc.).
Not only nutritional index, we will also investigate the relationship between frailty index, blood test data, CT values of L3-SMI and microbiota approximately 6 months after gastrostomy.
In the future, we will create a new predictive indicator for patient's prognosis and nutritional improvement index who planned to have gastrostomy from the results of this study.

Management information
Registered date
2020 Year 07 Month 30 Day
Last modified on
2020 Year 07 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047086

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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