Randomized, Double-Blind, Placebo-Controlled Trial of ID-CBT5101, a Tyndallized Clostridium butyricum Postbiotic, in Adults with Mild-to-Moderate Knee Osteoarthritis.

研究概要

Ninety-six patients with mild-to-moderate knee osteoarthritis were randomized to receive ID-CBT5101 (Clostridium butyricum postbiotic) or placebo. The primary outcome of interest was change from baseline in walking pain measured by a 100-mm visual analog scale (VAS). Secondary outcomes included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score, Korean Knee Score (KKS), patient global assessment, and serum inflammatory biomarkers (e.g., IL-6, COMP, PGE2, LTB4, TGF-β, hs-CRP). Outcomes were assessed over 12 weeks. Overall, the results of the study revealed that although both groups experienced significant within-group improvements in pain and function, there were no significant between-group differences for any clinical or biomarker outcomes. These findings suggest that while ID-CBT5101 is safe and well tolerated, it does not provide additional clinical benefit over placebo in this population.