UMIN-CTR Clinical Trial

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