Tokyo, Jan. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059733) titled 'Study of Synbiotic Supplementation for Improving Gastrointestinal Symptoms in Patients With Severe Stroke' on Jan. 1.

Study Type: Interventional

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

Primary Sponsor: Institute - Tokushima University

Condition: Condition - Stroke (cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to evaluate the effects of synbiotic supplementation on gastrointestinal symptoms, including gastric residual volume, constipation, and diarrhea, in patients with acute severe stroke receiving enteral nutrition. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Synbiotic supplementation (Synprotec, Yakult Honsha Co., Ltd.) will be administered twice daily (morning and evening) via a nasogastric tube. The intervention will be continued during the patient's stay in the stroke care unit, for up to a maximum of 14 days.

Eligibility: Age-lower limit - 18 years-old =15 who are admitted to our stroke care unit and initiated on enteral nutrition via a nasogastric tube. Key exclusion criteria - Pregnant or breastfeeding individuals Patients with conditions that preclude enteral nutrition (e.g., bowel obstruction, gastrointestinal perforation) Patients who have been regularly using synbiotic products prior to study initiation Patients with a known allergy or hypersensitivity to synbiotic products Patients (or their legal representatives) who decline participation in the study Target Size - 140

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 11 Month 14 Day Anticipated trial start date - 2026 Year 01 Month 01 Day Last follow-up date - 2031 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068293

Disclaimer: Curated by HT Syndication.