臨床研究等提出・公開システム

Scientific Title	Correlation testing of toxin-producing Clostridioides difficile toxin B detection reagents in stool samples.
Public Title	Correlation testing of toxin-producing Clostridioides difficile toxin B detection reagents in stool samples.

Contact for Scientific Queries	Name	Suzuki Hiromichi
	Affiliation	University of Tsukuba Hospital
	Address	2-1-1 Amakubo, Tsukuba, Ibaraki
	Telephone	+81-29-853-3682
	E-mail	hsuzuki@md.tsukuba.ac.jp
Contact for Public Queries	Name	Tanimura Naoki
	Affiliation	University of Tsukuba
	Address	1-1-1 Tennodai, Tsukuba, Ibaraki
	Telephone	+81-29-853-3682
	E-mail	tanimura.naoki.fw@un.tsukuba.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Nov. 25, 2023
Actual date of first enrollment		Nov. 16, 2023
Target sample size		700
Study Type		Observational
Study Design	allocation
	masking
	control
	assignment
	purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Existing residual stool samples with a Bristol stool scale of 5 or higher were collected for C. difficile testing.
	Exclusion Criteria	1) In the event that there were no residual samples to carry out this study. 2) If the toxin gene in the stool could not be detected within 5 days after collection"
	Age Minimum	No limit
	Age Maximum	No limit
	Gender
Health Condition(s) or Problem(s) Studied		Infectious diseases
Intervention(s)
Health Condition(s) Keyword		Infectious diseases
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Correlative evaluation of the existing method for toxin-producing C.difficile toxin B detection in stool samples using a dedicated reagent for the GeneLEAD series, a fully automated gene analysis instrument.
Secondary Outcome(s)		none

Primary Sponsor	University of Tsukuba Hospital

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Precision System Science Co., Ltd
Secondary Sponsor

Name of Certified Review Board	Ethics CommitteeUniversity of Tsukuba Hospital
Address	2-1-1 Amakubo, Tsukuba, Japan, Ibaraki
Telephone	+81-29-853-5669
E-Mail	t-credo.adm@un-tsukuba.ac.jp
Approval Status	Approval
Date of approval	Sept. 27, 2023

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Jan. 31, 2024	(this page)	Changes
1	Nov. 25, 2023	Detail

List of change history