臨床研究等提出・公開システム

Date of registration	Nov. 25, 2023
Last modified on	May. 27, 2026
Trial ID	jRCT1032230479

Scientific Title	Evaluation of the diagnostic characteristics of rapid testing for acute infectious enteritis.
Public Title	Evaluation of the diagnostic characteristics of rapid testing for acute infectious enteritis.

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		Sept. 01, 2023
Actual date of first enrollment		Mar. 18, 2024
Target sample size		500
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	Patients with symptoms consistent with acute infectious enteritis and for whom Gram stain fixation and antigen tests can be performed on collected stool samples within 24 hours.
	Exclusion Criteria	In the event, patients were requested to withdraw their consent.
	Age Minimum	No limit
	Age Maximum	No limit
Health Condition(s) or Problem(s) Studied		Infectious diseases
Health Condition(s) Keyword		Infectious diseases
Primary Outcome(s)		Evaluation of the test characteristics of antigen tests for Campylobacter spp. identification in stool samples.
Secondary Outcome(s)		Evaluation of gram staining and microscopic examination of stool samples was performed by physicians for Campylobacter spp. identification.

Primary Sponsor	University of Tsukuba Hospital

Source of Monetary Support / Secondary Sponsor	Denka Company Limited
Secondary Sponsor

Source of Monetary Support	Denka Company Limited
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. 01, 2023

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	May. 27, 2026	(this page)	Changes
2	Mar. 20, 2024	Detail	Changes
1	Nov. 25, 2023	Detail

List of change history