NIPH Clinical Trials Search

JRCT ID: jRCT1032230481

Registered date:25/11/2023

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

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedInfectious diseases
Date of first enrollment16/11/2023
Target sample size700
Countries of recruitment
Study typeObservational


Primary OutcomeCorrelative 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 Outcomenone

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximumNot applicable
Include criteriaExisting residual stool samples with a Bristol stool scale of 5 or higher were collected for C. difficile testing.
Exclude criteria1) 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"

Related Information


Public contact
Name Naoki Tanimura
Address 1-1-1 Tennodai, Tsukuba, Ibaraki Ibaraki Japan 305-8575
Telephone +81-29-853-3682
Affiliation University of Tsukuba
Scientific contact
Name Hiromichi Suzuki
Address 2-1-1 Amakubo, Tsukuba, Ibaraki Ibaraki Japan 305-8576
Telephone +81-29-853-3682
Affiliation University of Tsukuba Hospital