Tokyo, Oct. 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063225) titled 'An Exploratory Study on Longitudinal Changes in Urinary IgA Concentrations Among Junior High School Students During the High School Entrance Examination Period' on Oct. 13.

Study Type: Observational

Primary Sponsor: Institute - Yokohama National University

Condition: Condition - immunity Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - uring the entrance examination preparation period, major health management challenges for students include irregular lifestyle habits-such as chronic sleep deprivation, physical inactivity, and nutritional imbalances-as well as psychological burdens, including severe stress and anxiety. These factors often lead to physical and mental distress, accompanied by an increased risk of infectious diseases. Consequently, they can impair students' daily school life and undermine their physical and cognitive performance on examination days. Although various approaches have been explored to address these issues, few studies have addressed them from an immunological perspective. Immune status is likely linked both to upstream factors, such as lifestyle habits and psychological stress, and to downstream outcomes, such as infection risk. Therefore, quantifying individual immune status could serve a dual purpose: enabling students to evaluate the efficacy of lifestyle modifications and stress-reduction strategies, while fostering heightened awareness regarding infection prevention. This approach has the potential to contribute meaningfully to resolving the aforementioned challenges. As a critical first step, this study aims to assess longitudinal changes and fluctuations in immune status among students throughout the examination preparation period. Basic objectives2 - Bio-equivalence

Eligibility: Age-lower limit - 13 years-old = Gender - Male and Female Key inclusion criteria - This study will be conducted with second- and third-year students from our university-affiliated junior high schools. The eligibility criteria for participation are as follows: Second- or third-year male and female students enrolled at the Yokohama Junior High School or Kamakura Junior High School affiliated with Yokohama National University. Students whose parents or legal guardians have received a comprehensive explanation regarding the purpose and procedures of this study and have provided written informed consent for their child's participation. Students who received an explanation using an assent document and voluntarily agreed to participate. Key exclusion criteria - This study will be conducted with second- and third-year students from our university-affiliated junior high schools. The exclusion criteria for participation are as follows: Students who are unable to collect their own urine samples using the designated procedure. Students who have an autoimmune disease and are currently undergoing medical treatment or pharmacotherapy. Students who have kidney disease or renal dysfunction and are currently undergoing medical treatment or pharmacotherapy. Any other students deemed unsuitable for participation by the principal investigator. Target Size - 200

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 10 Month 13 Day Date of IRB - 2026 Year 10 Month 07 Day Anticipated trial start date - 2026 Year 10 Month 13 Day Last follow-up date - 2029 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072367

Disclaimer: Curated by HT Syndication.