UMIN-ICDS Clinical Trial

Public title

The interaction of nutrition, metagenomic and molecular gastric microenvironment factors in Helicobacter pylori-induced gastric carcinogenesis

Acronym

The interaction of nutrition, metagenomic and molecular gastric microenvironment factors in Helicobacter pylori-induced gastric carcinogenesis

Scientific Title

The interaction of nutrition, metagenomic and molecular gastric microenvironment factors in Helicobacter pylori-induced gastric carcinogenesis

Scientific Title:Acronym

The interaction of nutrition, metagenomic and molecular gastric microenvironment factors in Helicobacter pylori-induced gastric carcinogenesis

Region

Japan

Europe

Condition

Helicobacter pylori-infected gastric cancer patients, Helicobacter pylori-infected gastritis patients, Helicobacter pylori non-infected patients

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Helicobacter pylori (H. pylori) infection is known to be a major factor in gastric carcinogenesis, but basic research shows that H. pylori alone does not cause gastric carcinogenesis, suggesting that a specific gastric environment promotes gastric carcinogenesis. It is assumed that In this study, we targeted gastric cancer patients in both Japan and Lithuania, both of which have a high risk of developing gastric cancer, and patients with atrophic gastritis, a precancerous lesion of gastric cancer. Comprehensively analyze not only toxin subtypes, but also gastric flora profile, micro RNA profile in exosomes, differences in short-chain fatty acid (SFCA) concentration in the gastric environment, and differences in dietary habits. to analyze the factors that promote the risk of gastric carcinogenesis. Basic research has pointed out the possibility that SFCA, which is produced by specific bacteria from soluble dietary fiber, has the function of promoting gastric carcinogenesis. A surface-focused analysis is intended.
In this study, Japan and Lithuania will share experimental methods and techniques such as analysis of toxin subtypes derived from H. pylori strains, analysis of gastric flora, micro RNA profiling in exosomes, and measurement of gastric SFCA concentration. In addition, we will share methods for quantifying dietary habits with objective indicators and methods for endoscopically evaluating atrophic gastritis, a precancerous lesion associated with H. pylori infection and known as a risk of gastric carcinogenesis. By doing so, it will be possible to share standards for global evaluation methods in gastric cancer treatment between Japan and Lithuania. As a result, it is expected that the method of this research will be used as a golden standard for similar research in the future.

Basic objectives2

Bio-equivalence

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

To identify and compare changes in nutrients, metagenomic factors, metabolites, and microRNA molecules in gastric carcinogenesis by Helicobacter pylori, and to evaluate the interaction of these gastric microenvironmental factors.

Key secondary outcomes

1) To examine changes in gastric microbiome and microRNA profiles in gastric cancer patients and compare these profiles between Lithuanian and Japanese gastric cancer patients.
2) Investigate changes in the amount of short-chain fatty acids in the gastric juice of gastric cancer patients, and compare the amounts with those of non-H. pylori-infected individuals.
3) Evaluate the relationship between the amount of short-chain fatty acids in gastric juice and nutritional factors, and compare the results between Lithuanian and Japanese subjects.
4) Quantify the expression of CD44v9 and CAPZA1 in gastric tissue and compare the differences in expression of these genes between Japanese and Lithuanian patients.
5) Investigate the subtype of CagA, the virulence factor of Helicobacter pylori, and compare between Japanese and Lithuanian.
6) To identify metagenomic and microRNA factors associated with gastric premalignancy (atrophic gastritis) and compare them between Japanese and Lithuanian subjects.

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

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

-Those who plan to undergo upper gastrointestinal endoscopy within 1 year from the date of consent to participate in this study
-Subjects who have received a sufficient explanation about participating in this research and have obtained written consent of their own free will.

Key exclusion criteria

-Patients who regularly use PPI, PCAB, H2blocker as acid secretion inhibitors
-Persons with high bleeding risk in histological examination
-In addition, those who are judged inappropriate by the research director or co-investigators

Target sample size

90

Name of lead principal investigator

1st name	Hidekazu
Middle name
Last name	Suzuki

Organization

Tokai University School of Medicine

Division name

Division of Gastroenterology and Hepatology Department of Internal Medicine

Zip code

259-1193

Address

143 Shimokasuya, Isehara, Kanagawa

TEL

0463-93-1121

Email

hsuzuki@tokai.ac.jp

Name of contact person

1st name	Hidekazu
Middle name
Last name	Suzuki

Organization

Tokai University School of Medicine

Division name

Division of Gastroenterology and Hepatology Department of Internal Medicine

Zip code

259-1193

Address

143 Shimokasuya, Isehara, Kanagawa

TEL

0463-93-1121

Homepage URL

Email

hsuzuki@tokai.ac.jp

Institute

Tokai University

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

University of Shizuoka,School of Pharmaceutical Sciences
Shizuoka Graduate University of Public Health
National Institute of Public Health
Keio University School of medicine
Lithuanian University of Health Sciences

Name of secondary funder(s)

Organization

Institutional Review Board for Clinical Research, Tokai University

Address

143 Shimokasuya, Isehara, Kanagawa

Tel

0463-93-1121

Email

tokai-rinsho@ml.tokai-u.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

2023

Year

02

Month

01

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

2022

Year

04

Month

01

Day

Date of IRB

2022

Year

02

Month

14

Day

Anticipated trial start date

2022

Year

04

Month

01

Day

Last follow-up date

2025

Year

10

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

NA

Registered date

2023

Year

01

Month

31

Day

Last modified on

2023

Year

02

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056945