Study on the usefulness of fecal calprotectin in ulcerative colitis and the relevance of other biomarkers

Study on the usefulness of fecal calprotectin by gold colloid agglutination in ulcerative colitis and the relevance of other biomarkers - UC-CAL Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000052832

Enrollment

150

Registered

2023-11-17

Start date

2023-10-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative colitis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients aged 18-80 years with ulcerative colitis or non-ulcerative colitis and symptomatic conditions scheduled for close examination by colonoscopy.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Japan

Contacts

Public ContactMirai Hayashi

Ehime University Graduate School of Medicine Department of Gastroenterology and Metabology

3naika@m.ehime-u.ac.jp0899605308

Outcome results