UMIN-CTR Clinical Trial

Basic information
Public title	Analysis of lymphocyte composition in the gastric mucosa after Helicobacter pylori eradication
Acronym	Lymphocyte composition after H. pylori eradication
Scientific Title	Analysis of lymphocyte composition in the gastric mucosa after Helicobacter pylori eradication
Scientific Title:Acronym	Lymphocyte composition after H. pylori eradication
Region	Japan

Condition
Condition	Post-Helicobacter pylori eradication
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the composition of lymphocytes in each part of the stomach
Basic objectives2	Others
Basic objectives -Others	Biological features
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Revealing lymphocyte composition of each part of the stomach
Key secondary outcomes

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	20 years-old <=
Age-upper limit	99 years-old >=
Gender	Male and Female
Key inclusion criteria	post-H. pylori eradication
Key exclusion criteria	Women who are pregnant or may be pregnant
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Masaya Middle name Last name Iwamuro
Organization	Okayama University Hospital
Division name	Department of Gastroenterology and Hepatology
Zip code	700-8558
Address	2-5-1 Shikata-cho, Kita-ku, Okayama
TEL	0862357218
Email	iwamuromasaya@yahoo.co.jp

Public contact
Name of contact person	1st name Masaya Middle name Last name Iwamuro
Organization	Okayama University Hospital
Division name	Department of Gastroenterology and Hepatology
Zip code	700-8558
Address	2-5-1 Shikata-cho, Kita-ku, Okayama
TEL	0862357218
Homepage URL
Email	iwamuromasaya@yahoo.co.jp

Sponsor
Institute	Okayama University
Institute
Department

Funding Source
Organization	Okayama University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Okayama University Hospital
Address	2-5-1 Shikata-cho, Kita-ku, Okayama
Tel	0862357218
Email	iwamuromasaya@yahoo.co.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 06 Month 08 Day

Related information
URL releasing protocol	https://journals.lww.com/md-journal/Fulltext/2022/08260/Site_specific_differences_in_T_lymphocyte.71
Publication of results	Published

Result
URL related to results and publications	https://journals.lww.com/md-journal/Fulltext/2022/08260/Site_specific_differences_in_T_lymphocyte.71
Number of participants that the trial has enrolled	20
Results	The lymphocyte subsets of the antrum and lesser curvature of the body were similar. In contrast, compared to those in the greater curvature of the gastric body, CD4+/CD3+ lymphocyte subsets were elevated in the lesser curvature of the body, whereas CD8+/CD3+, CD7+/CD3+, CCR4+/CD3+, CD45RA+/CD3+CD4+, and CD45RA+/CD3+CD4- were lower. Linear regression analysis showed a negative correlation between the time after H. pylori eradication and CD4+/CD3+.
Results date posted	2022 Year 12 Month 08 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	To investigate site-specific differences in stomach-resident T lymphocytes after H. pylori eradication, we performed flow cytometry analysis on samples taken from the gastric antrum, greater curvature of the gastric body, and lesser curvature of the gastric body of 20 patients.
Participant flow	To investigate site-specific differences in stomach-resident T lymphocytes after H. pylori eradication, we performed flow cytometry analysis on samples taken from the gastric antrum, greater curvature of the gastric body, and lesser curvature of the gastric body of 20 patients.
Adverse events	none
Outcome measures	site-specific differences in stomach-resident T lymphocytes
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2020 Year 06 Month 05 Day
Date of IRB	2020 Year 06 Month 05 Day
Anticipated trial start date	2020 Year 06 Month 08 Day
Last follow-up date	2021 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2020 Year 06 Month 06 Day
Last modified on	2022 Year 12 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046423