Tokyo, Oct. 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063204) titled 'Observational Study of Secretory Immunoglobulin A (s-IgA) in IBD Patients and Control Subjects' on Oct. 10.
Study Type:
Observational
Primary Sponsor:
Institute - Juntendo University
Condition:
Condition - Ulcerative colitis, Crohn's disease
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study aims to compare salivary IgA (s-IgA) levels between patients with IBD and individuals without IBD (controls) by assessing IBD symptoms and disease activity, and by measuring IgA in collected saliva and blood samples.
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - 1. Aged 20 to 80 years at the time of obtaining consent
2. Individuals who voluntarily consent to participate in the study after fully understanding its purpose and content
3. Individuals who meet either of the following criteria:
a) Diagnosed with IBD based on a physician's assessment
b) Free of IBD symptoms and with a fecal calprotectin level of 50.0 mg/kg or less
Key exclusion criteria - 1. Individuals for whom saliva collection is difficult (e.g., due to xerostomia)
2. Individuals whose saliva may contain blood (e.g., due to oral conditions involving bleeding)
3. Any other individuals deemed unsuitable as study participants by the principal investigator
Target Size - 60
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2025 Year 03 Month 07 Day
Date of IRB - 2025 Year 03 Month 07 Day
Anticipated trial start date - 2025 Year 04 Month 20 Day
Last follow-up date - 2027 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072339
Disclaimer: Curated by HT Syndication.
