■在雌激素缺乏小鼠模型和老年妇女中,每日补充益生菌罗伊氏肝菌ATCCPTA6475(Lreuteri)与安慰剂相比,先前已被证明可以减少骨质流失。尽管影响的幅度很小。我们假设用罗伊氏长期治疗可导致绝经后骨质疏松症的临床相关骨骼益处。
■评估每日补充罗伊氏与安慰剂是否可以减少绝经后早期骨丢失,以及在2年的治疗期间,效果是否随着时间的推移而保持或增加。
■双盲,随机化,安慰剂对照临床试验于2019年12月4日至2022年10月6日之间在哥德堡的一个中心进行,瑞典西南部。参与者是通过网络广告招募的,并向10062名年龄在50至60岁之间的妇女发送了信件。回答的女性(n=752)接受了电话筛查,导致292名女性被邀请参加筛查访问。在那些被筛查的人中,239名女性符合所有纳入标准,没有排除标准。
■2剂罗伊利胶囊,5×108(低剂量)或5×109(高剂量)菌落形成单位,每天服用两次或服用安慰剂。所有胶囊还包括胆钙化醇,200IU。
■主要结果是2年内胫骨总体积骨矿物质密度(vBMD)的相对变化。次要结果包括腰椎和全髋关节的区域BMD的相对变化,骨转换标记物I型胶原和I型前胶原完整N端前肽的C端端肽交联,以及胫骨骨小梁体积分数和皮质vBMD。进行了意向治疗和符合方案分析。
■共有239名绝经后妇女(中位年龄,55[IQR,53-56]年)被包括在内。胫骨vBMD(主要结果),髋部和脊柱vBMD,胫骨皮质面积和骨密度在所有组显著下降,没有组间差异(胫骨vBMD高剂量与安慰剂最小二乘平均值的百分比变化,-0.08[95CI,-0.85至0.69]和低剂量与安慰剂的最小二乘平均值,-0.22[95%CI,-0.99至0.55])。对任何其他预定义的结果没有显著的治疗效果。预先设定的敏感性分析发现,体重指数(BMI)与2年时的治疗效果之间存在显着相互作用。没有观察到明显的不良反应。
■在这项针对239名绝经后早期妇女的随机临床试验中,补充罗伊氏L在2年内对骨丢失或骨转换无影响.观察到的BMI与治疗效果之间的相互作用值得进一步研究。
■ClinicalTrials.gov标识符:NCT04169789。
UNASSIGNED: Daily supplementation with the probiotic Limosilactobacillus reuteri ATCC PTA 6475 (L reuteri) vs placebo has previously been demonstrated to reduce bone loss in an estrogen deficiency mice model and older women, although the magnitude of the effect was small. We hypothesized that long-term treatment with L reuteri could result in clinically relevant skeletal benefits in postmenopausal osteoporosis.
UNASSIGNED: To evaluate whether daily supplementation with L reuteri vs placebo could reduce early postmenopausal bone loss and whether the effects remained or increased over time during 2 years of treatment.
UNASSIGNED: A double-blind, randomized, placebo-controlled clinical trial was conducted between December 4, 2019, and October 6, 2022, at a single center in Gothenburg, southwestern Sweden. Participants were recruited by online advertisements, and letters were sent to 10 062 women aged 50 to 60 years. Responding women (n = 752) underwent telephone screening, resulting in 292 women being invited to a screening visit. Of those who were screened, 239 women met all inclusion criteria and had no exclusion criteria.
UNASSIGNED: Capsules with L reuteri in 2 doses, 5 × 108 (low dose) or 5 × 109 (high dose) colony-forming units, taken twice daily or placebo were administered. All capsules also included cholecalciferol, 200 IU.
UNASSIGNED: The primary outcome was the relative change in tibia total volumetric bone mineral density (vBMD) over 2 years. Secondary outcomes included relative change in areal BMD of the lumbar spine and total hip, bone turnover markers C-terminal telopeptide cross-links of collagen type I and type I procollagen intact N-terminal propeptide, as well as tibia trabecular bone volume fraction and cortical vBMD. Both intention-to-treat and per-protocol analyses were conducted.
UNASSIGNED: A total of 239 postmenopausal women (median age, 55 [IQR, 53-56] years) were included. Tibia vBMD (primary outcome), hip and spine vBMD, and tibia cortical area and BMD decreased significantly in all groups, with no group-to-group differences (percent change tibia vBMD high dose vs placebo least-squares means, -0.08 [95 CI, -0.85 to 0.69] and low dose vs placebo least-squares means, -0.22 [95% CI, -0.99 to 0.55]). There were no significant treatment effects on any other predefined outcomes. A prespecified sensitivity analysis found a significant interaction between body mass index (BMI) and treatment effect at 2 years. No significant adverse effects were observed.
UNASSIGNED: In this randomized clinical trial of 239 early postmenopausal women, supplementation with L reuteri had no effect on bone loss or bone turnover over 2 years. The observed interaction between BMI and treatment effect warrants further investigation.
UNASSIGNED: ClinicalTrials.gov Identifier: NCT04169789.