Tokyo, March 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060766) titled 'Efficacy of Synbiotic Supplementation in Acute Severe Cardiovascular Disease Patients' on March 31.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Historical

Primary Sponsor: Institute - Hyogo Prefectural Amagasaki General Medical Center

Condition: Condition - severe cardiovascular disease Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the efficasy of administering synbiotic supplementation to critically ill cardiac patients admitted to the CCU under acute ventilator management, along with the initiation of enteral nutrition, on gastrointestinal symptoms such as constipation and diarrhea, and infectious complications. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - Synbiotic supplementation (Synprotec, Yakult Honsha Co., Ltd.) will be administered three times a day via a nasogastric tube. The intervention will be continued during the patient's stay in the cardiac care unit, for up to a maximum of 10 days

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Adult patients with acute severe cardiac disease who required ventilator management and were admitted to our hospital's CCU and who were started on enteral nutrition via a nasogastric tube Key exclusion criteria - Pregnant or nursing patients Patients with medical conditions that preclude enteral nutrition (e.g., intestinal obstruction, gastrointestinal perforation) Patients who have been continuously using synbiotic supplementation prior to the start of the study Patients with a history of allergies to synbiotic supplementation Patients (or their legal representatives) decline to participate in the study Target Size - 360

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2023 Year 03 Month 01 Day Anticipated trial start date - 2026 Year 04 Month 01 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=R000069417

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