Lyu Jia-Ling, Wang Ting-Ming, Chen Yen-Hao, Chang Shu-Ting, Wu Ming-Shiang, Lin Yung-Hao, Lin Yung-Hsiang, Kuan Chen-Meng
Research & Design Center, TCI CO., Ltd., Taipei, 114, Taiwan.
Department of Cosmeceutics, China Medical University, Taichung, 404, Taiwan.
Heliyon. 2020 Apr 25;6(4):e03757. doi: 10.1016/j.heliyon.2020.e03757. eCollection 2020 Apr.
This preliminary clinical study demonstrates the possibility of a new species of probiotic for improvement of the degeneration of knee osteoarthritis (KOA). TCI633 ( ) is a newly founded bacterium from human breast milk, and it is able to produce hyaluronate (HA) in gastrointestinal (GI) tract. A recent study has proved that TCI633 can substantially alleviate synovial tissue inflammation and cartilage damage in the animal models, but so far it has never been applied in clinical intervention. In this study, we recruited 80 subjects and conducted 12 weeks clinical trial to validate the efficacy of TCI633 for improvement of the progression of KOA. TCI633 could improve serum collagen type II C-telopeptide (sCTX-II) and serum C-reactive protein (sCRP) by 41.58% and 39.58%, respectively, after the study. The improvement rates for sCTX-II and sCRP in TCI633 group were 54% and 57%, respectively, at 12 weeks. Compared to the results of placebo, the indistinct improvement progresses of sCTX-II and sCRP might be caused by the uneventful distribution of K/L populations between the TCI633 and placebo groups, a short term of study period, and few recruited subjects. Moreover, the results of Western Ontario and McMaster Universities (WOMAC) questionnaires show that TCI633 might retard the progression and development of KOA after the trial. In brief, this preliminary research may provide an alternative approach to the improvement of KOA by probiotics although more detailed investigations should be conducted for solid conclusions.
这项初步临床研究证明了一种新型益生菌改善膝关节骨关节炎（KOA）退变的可能性。TCI633（ ）是一种从人母乳中新发现的细菌，它能够在胃肠道（GI）中产生透明质酸盐（HA）。最近的一项研究证明，TCI633可以在动物模型中显著减轻滑膜组织炎症和软骨损伤，但迄今为止它从未应用于临床干预。在本研究中，我们招募了80名受试者并进行了为期12周的临床试验，以验证TCI633改善KOA进展的疗效。研究结束后，TCI633可使血清II型胶原C末端肽（sCTX-II）和血清C反应蛋白（sCRP）分别改善41.58%和39.58%。在12周时，TCI633组sCTX-II和sCRP的改善率分别为54%和57%。与安慰剂结果相比，sCTX-II和sCRP改善进展不明显可能是由于TCI633组和安慰剂组之间K/L人群分布均匀、研究期短以及招募的受试者较少。此外，西安大略和麦克马斯特大学（WOMAC）问卷结果显示，试验后TCI633可能会延缓KOA的进展和发展。简而言之，这项初步研究可能为通过益生菌改善KOA提供一种替代方法，尽管还需要进行更详细的研究以得出确凿结论。
