Tokyo, Jan. 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060343) titled 'Effects of Synbiotic Supplementation on Muscle Health, and Activities of Daily Living in Hospitalized Stroke Patients with Sarcopenia' on Jan. 13.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Placebo

Primary Sponsor: Institute - Other

Condition: Condition - Patients with post-stroke sarcopenia Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study evaluates whether adding synbiotics (Yakult 400W) to standard rehabilitation improves skeletal muscle mass, muscle strength, and ADL in elderly stroke patients with sarcopenia admitted to a recovery-phase rehabilitation ward. It also assesses the feasibility of the intervention to establish a foundation for conducting a future full-scale randomized controlled trial. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Intervention product: Yakult 400W (80mL/once daily) Intervention period: 8 weeks Administered orally at breakfast time. Daily nutritional intake shall be hospital meals tailored to activity levels. Interventions/Control_2 - Control: Milk 100 (100mL/once daily) Intervention period: 8 weeks Administered orally at breakfast time. Daily nutritional intake shall be hospital meals tailored to activity levels.

Eligibility: Age-lower limit - 65 years-old 6) Key exclusion criteria - Exclude subjects meeting any of the following criteria: 1) Acute inflammation or active chronic inflammation within the past 4 weeks 2) Currently receiving antimicrobial therapy 3) Severe renal impairment (eGFR < 15 mL/min/1.73m2) 4) History of allergy to probiotics, prebiotics, or dairy products 5) Subject deemed inappropriate by the principal investigator Target Size - 80

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 12 Month 19 Day Date of IRB - 2025 Year 12 Month 26 Day Anticipated trial start date - 2026 Year 01 Month 19 Day Last follow-up date - 2028 Year 06 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069027

Disclaimer: Curated by HT Syndication.