Tokyo, June 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061978) titled 'Comprehensive analysis of bacterial flora and metabolome in necrotic tissue of infected walled-off necrosis, and the effects of antibiotics and antifungal drugs: a prospective observational study' on June 19.

Study Type: Observational

Primary Sponsor: Institute - The University of Tokyo

Condition: Condition - Infected walled-off necrosis Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To elucidate longitudinal changes in microbiome composition (bacteria by 16S rRNA gene sequencing, fungi by ITS1 sequencing) and microbial metabolite profiles (by untargeted LC-MS/MS metabolomics) in necrotic tissue of infected walled-off necrosis (WON), and to evaluate the impact of antibiotic and antifungal therapy on the local microbial and metabolic environment. Basic objectives2 - Others

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Age 18 years or older 2. Diagnosed with infected walled-off necrosis (WON) 3. Scheduled for endoscopic treatment including necrosectomy or drainage 4. Able to provide written informed consent (patients with severely impaired consciousness at or shortly after admission may be enrolled via opt-out procedure) Key exclusion criteria - 1. Age under 18 years 2. Patients who have explicitly refused participation in the study 3. Patients deemed inappropriate for participation at the investigator's discretion 4. Patients in whom specimen collection is judged medically difficult or inappropriate due to severe systemic condition or organ failure Target Size - 30

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2025 Year 10 Month 21 Day Date of IRB - 2026 Year 06 Month 17 Day Anticipated trial start date - 2025 Year 11 Month 10 Day Last follow-up date - 2030 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070918

Disclaimer: Curated by HT Syndication.