Latilactobacillus sakei

  • 文章类型: Randomized Controlled Trial
    肥胖是影响生活质量的全球性健康问题。它是主要医疗状况的多维慢性危险因素,比如心血管疾病,糖尿病,和癌症。这项临床试验评估了沙生乳杆菌OK67(DW2010)的疗效,一种乳酸菌,在减少超重个体的身体和内脏脂肪(体重指数≥25kg/m2和<30kg/m2),20-60岁。在生活方式改变计划中,共有100名受试者被随机分配接受DW2010(2.0克/天,1.0×1010CFU)或安慰剂12周。通过使用双能X线吸收法测量体脂质量和使用计算机断层扫描测量内脏脂肪面积来评估DW2010的疗效。12周后,DW2010组的体脂变化与安慰剂组没有显著差异.然而,与安慰剂组相比,DW2010组的内脏脂肪面积减少更多(p=0.035).在临床试验中,未报告重大不良事件.此外,DW2010组和安慰剂组的生化指标无统计学差异.总的来说,我们得出的结论是,在生活方式改变的超重受试者中,12周摄入DW2010是安全的,并且有可能减少内脏脂肪.
    Obesity is a global health problem that affects the quality of life. It is a multidimensional chronic risk factor for major medical conditions, such as cardiovascular diseases, diabetes, and cancer. This clinical trial evaluated the efficacy of Lactobacillus sakei OK67 (DW2010), a lactic acid bacterium, in reducing body and visceral fat in overweight individuals (body mass index ≥25 kg/m2 and <30 kg/m2), aged 20-60 years. A total of 100 subjects placed in a lifestyle modification program were randomly assigned to receive either DW2010 (2.0 g/day, 1.0 × 1010 CFU) or a placebo for 12 weeks. The efficacy of DW2010 was evaluated by measuring body fat mass using dual-energy X-ray absorptiometry and visceral fat area using computed tomography. After 12 weeks, the change in body fat in the DW2010 group was not markedly different from that in the placebo group. However, visceral fat area decreased more in the DW2010 group than in the placebo group (p = 0.035). During the clinical trial, no major adverse events were reported. Moreover, no statistical differences were observed in the biochemical parameters of the DW2010 and placebo groups. Overall, we concluded that the intake of DW2010 for 12 weeks is safe and potentially reduces visceral fat in lifestyle-modified overweight subjects.
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  • 文章类型: Journal Article
    干眼病(DED)是最常见的眼病之一。本研究旨在评估沙生乳杆菌(L.sakei)作为眼科细菌裂解物(滴剂,没有活的生物体)或作为DED患者的免疫和临床结局的口服益生菌(胶囊)。这项研究是随机的,安慰剂对照,具有四个平行臂的三重掩蔽临床试验。患者以2x2阶乘设计随机分配,组合活性与安慰剂胶囊和活性与安慰剂滴眼液,比例为1:1x1:1。眼用滴剂被批准在欧盟用作医疗设备(CE注册码0425-MED-004235)。共评估了40例患者。与安慰剂相比,使用活性滴剂可显着降低DED体征和症状,通过眼表疾病指数(OSDI)测量,撕裂破裂时间(TBUT),和SchirmerI测试(所有p<0.0001)。相反,与安慰剂相比,活性胶囊及其与活性滴剂的相互作用均未达到显着。IL-6的泪液水平也显著降低(p=0.0007),TNFα(p<0.0001),和IFNγ(p<0.0001)在接受活性滴剂的患者中。两种活性产品(滴剂和胶囊)的摄取都是良好耐受的。含有沙生乳球菌裂解物的益生菌眼用制剂显著改善了DED的体征和症状,并抑制了眼表炎性反应。相反,这些患者口服L.sakei作为益生菌胶囊没有影响(ClinicalTrials.gov:NCT04938908).
    Dry eye disease (DED) is one of the most prevalent eye diseases. This study aimed to evaluate the efficacy and safety of Latilactobacillus sakei (L. sakei) either as an ophthalmic bacterial lysate (drops, no live organism) or as an oral probiotic (capsules) on immunological and clinical outcomes of patients with DED. This study was a randomized, placebo-controlled, triple-masking clinical trial with four parallel arms. Patients were randomly assigned in a 2x2 factorial design combining active vs placebo capsules and active vs placebo eye drops in a 1:1x1:1 ratio. The ophthalmic drops are approved for use in the European Union as a medical device (CE registration code 0425-MED-004235). A total of 40 patients were evaluated. DED signs and symptoms decreased significantly by using active drops compared to placebo, as measured by the Ocular Surface Disease Index (OSDI), Tear Break-up Time (TBUT), and Schirmer I tests (all p<0.0001). Conversely, neither active capsules nor their interaction effect with active drops achieved significance vs placebo. There was also a significant decrease in the tear levels of IL-6 (p=0.0007), TNFα (p<0.0001), and IFNγ (p<0.0001) in patients receiving active drops. Intake of both active products (drops and capsules) was well tolerated. Postbiotic ophthalmic formulation containing L. sakei lysate significantly improved the signs and symptoms of DED and suppressed ocular surface inflammatory response. Conversely, oral intake of L.sakei as a probiotic capsule had no effect in these patients (ClinicalTrials.gov: NCT04938908).
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