Study on the usefulness of fecal calprotectin in ulcerative colitis and the relevance of other biomarkers
Not Applicable
Recruiting
- Conditions
- lcerative colitis
- Registration Number
- JPRN-UMIN000052832
- Lead Sponsor
- Ehime University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
Not provided
Exclusion Criteria
Persons who are unable to give their consent. Persons who cannot understand the explanation. Persons who are judged to be unable to undergo colonoscopy due to their general condition. Persons whose prothrombin time is less than 50% or platelet count is less than 50,000/microl in the blood test. Persons deemed unsuitable by the principal investigator.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To clarify the usefulness of the gold colloid agglutination method in patients with ulcerative colitis by analysing the correlation between the gold colloid agglutination method and the FEIA stool calprotectin test at the time of colonoscopy.
- Secondary Outcome Measures
Name Time Method To assess reagent and instrument performance in order to assess whether the stool calprotectin values obtained in the main evaluation are adequate. To assess the correlation between stool calprotectin values obtained in the main evaluation and existing biomarkers. To assess the correlation between existing biomarkers. To assess the correlation between stool calprotectin levels and existing biomarkers obtained in the main evaluation and clinical scores or histopathological findings, and how they are assessed in combination. Evaluate the ability of stool calprotectin levels and existing biomarkers obtained in the main evaluation to discriminate between patients with non-ulcerative colitis and patients with ulcerative colitis, or to discriminate between patients with ulcerative colitis and patients with ulcerative colitis in terms of disease activity. Using the first faecal evacuation during colonoscopy, assess the stability of stool markers in stool and in the stool sample after adjustment.