UMIN-CTR Clinical Trial

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

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

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

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.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

The Jikei University School of Medicine

Institute

Department

Personal name

Organization

The Uehara Memorial Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Institute of Physical and Chemical Research(RIKEN), International University of Health and Welfare (IUWH)

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2020

Year

07

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

Registered date

2020

Year

07

Month

30

Day

Last modified on

2020

Year

07

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047086