Attaye Ilias, Bird Julia K, Nieuwdorp Max, Gül Sahin, Seegers Jos F M L, Morrison Steven, Hofkens Stijn, Herrema Hilde, Bui Nam, Puhlmann Marie-Luise, de Vos Willem M
Department of Internal and Vascular Medicine, Amsterdam University Medical Centers, The Netherlands.
Amsterdam Cardiovascular Sciences, Diabetes & Metabolism, Amsterdam, The Netherlands.
Gut Microbes. 2025 Dec;17(1):2504115. doi: 10.1080/19490976.2025.2504115. Epub 2025 May 15.
(previously ) is a butyrate-producing next-generation beneficial microbe generally recognized as safe. Several short-term intervention trials by L2-7 have shown improvement of insulin sensitivity in prediabetic subjects and type 2 diabetes patients. To determine the long-term cardiometabolic benefits and safety, we performed a 3-month double-blind, randomized placebo-controlled intervention in 98 prediabetic insulin-resistant adults in Europe and U.S. with daily administration of encapsulated cells of CH-106, a tetracycline-sensitive isogenic derivative of strain L2-7. Compared to placebo, -treated subjects showed significantly reduced glycemic variability (1% reduction in the coefficient of variation; = 0.01) and improved glycemic control (6% reduction in the overall net glycemic action-1; < 0.05), including reduced serum glycated hemoglobin (HbA1c) levels when including the 4-week washout period (1 mmol/mol reduction; < 0.05). Moreover, diastolic blood pressure was significantly reduced in all -treated subjects (3 mm Hg; < 0.05). The study product was well-tolerated and had no effect on the global intestinal microbiota composition, including alpha and beta-diversity, besides an increased abundance of in the treatment group, indicative of compliance. The U.S. participants, compared to those in Europe, responded best, notably in the oral glucose tolerance tests (15% improvement in the area-under-the curve of plasma glucose levels; = 0.039) or coefficient of variation (reduction of 3.1%; < 0.05). This potentially relates to a more severe prediabetic state in U.S. subjects, associated with significantly reduced (1.5-3.5-fold) relative abundance of , spp. and two-fold increased relative abundance of spp. In conclusion, daily oral supplementation with was safe and improved various markers of glycemic control, reduced HbA1c levels and diastolic blood pressure, indicating a novel microbiome-based approach to improve cardio-metabolic health in adults at risk for developing type 2 diabetes. NCT04529473, clinicaltrials.gov supplementation improves #cardio-metabolic health in subjects at risk for type 2 #diabetes.
（之前）是一种产生丁酸盐的下一代有益微生物，一般公认为安全。L2 - 7进行的几项短期干预试验表明，糖尿病前期受试者和2型糖尿病患者的胰岛素敏感性有所改善。为了确定长期的心脏代谢益处和安全性，我们对欧洲和美国98名糖尿病前期胰岛素抵抗成年人进行了为期3个月的双盲、随机安慰剂对照干预，每日给予L2 - 7菌株的四环素敏感同基因衍生物CH - 106的包囊化细胞。与安慰剂相比，接受治疗的受试者血糖变异性显著降低（变异系数降低1%；P = 0.01），血糖控制得到改善（总体净血糖作用降低6%；P < 0.05），包括纳入4周洗脱期后血清糖化血红蛋白（HbA1c）水平降低（降低1 mmol/mol；P < 0.05）。此外，所有接受治疗的受试者舒张压均显著降低（降低3 mmHg；P < 0.05）。该研究产品耐受性良好，除治疗组中某菌属丰度增加表明依从性外，对包括α和β多样性在内的整体肠道微生物群组成无影响。与欧洲参与者相比，美国参与者反应最佳，尤其是在口服葡萄糖耐量试验中（血浆葡萄糖水平曲线下面积改善15%；P = 0.039）或变异系数（降低3.1%；P < 0.05）。这可能与美国受试者更严重的糖尿病前期状态有关，其特征是某几个菌属的相对丰度显著降低（1.5至3.5倍），而另一菌属的相对丰度增加两倍。总之，每日口服补充该菌属安全，改善了血糖控制的各项指标，降低了HbA1c水平和舒张压，表明一种基于微生物群的新方法可改善有2型糖尿病风险的成年人的心脏代谢健康。NCT04529473，clinicaltrials.gov补充剂改善2型糖尿病风险受试者的心脏代谢健康。
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