UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041254
Receipt number 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 09:32:36

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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 or person

Institute

The Jikei University School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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