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严重肥胖和代谢综合征患者中粪便微生物移植和纤维补充的临床试验
2021-07-08 16:51

加拿大阿尔伯塔大学Karen L. Madsen课题组完成严重肥胖和代谢综合征患者中粪便微生物移植和纤维补充的临床试验。这一研究成果于2021年7月5日在线发表在国际学术期刊《自然—医学》上。

研究人员测试了每日补充纤维作为粪便微生物移植(FMT)疗法的辅助手段来调节心脏代谢结果的应用。研究人员对接受口服FMT的严重肥胖和代谢综合征患者进行了一项双盲随机试验,用于测试高发酵(HF)和低发酵(LF)纤维补充剂(NCT03477916)。70名参与者被随机分配到FMT-HF(n=17)、FMT-LF(n=17)、HF(n=17)和LF(n=19)组。主要结果是使用稳态模型评估(HOMA2-IR/IS)来测量胰岛素敏感性从基线到6周的变化。6 周后,只有FMT-LF组患者的HOMA2-IR显著改善(6周时为3.16±3.01,而基线时为3.77±3.57;P=0.02)。

在此期间,FMT-HF组的HOMA2-IR没有差异(6周时为3.25±1.70,基线时为3.17±1.72;P=0.8),HF组(6周时为3.49±1.43,基线时为3.26±1.33;P=0.8)或LF组(6周时为3.76±2.01,基线时为3.56±1.81;P=0.8)。干预措施安全且耐受性良好,没有治疗引起的严重不良事件。因此,这项研究提供了使用单剂量口服FMT结合每日低发酵纤维补充剂来改善严重肥胖和代谢综合征患者胰岛素敏感性的概念证明。

据悉,从瘦者到肥胖患者的FMT与代谢益处相关,但迄今为止的结果并不一致。

附:英文原文

Title: Fecal microbial transplantation and fiber supplementation in patients with severe obesity and metabolic syndrome: a randomized double-blind, placebo-controlled phase 2 trial

Author: Valentin Mocanu, Zhengxiao Zhang, Edward C. Deehan, Dina H. Kao, Naomi Hotte, Shahzeer Karmali, Daniel W. Birch, Kalutota K. Samarasinghe, Jens Walter, Karen L. Madsen

Issue&Volume: 2021-07-05

Abstract: Fecal microbial transplantation (FMT) from lean donors to patients with obesity has been associated with metabolic benefits, yet results so far have been inconsistent. In this study, we tested the application of daily fiber supplementation as an adjunct to FMT therapy to modulate cardiometabolic outcomes. We performed a double-blind randomized trial in patients with severe obesity and metabolic syndrome receiving oral FMT, to test high-fermentable (HF) and low-fermentable (LF) fiber supplements (NCT03477916). Seventy participants were randomized to the FMT-HF (n=17), FMT-LF (n=17), HF (n=17) and LF (n=19) groups. The primary outcome was the assessment of change in insulin sensitivity from baseline to 6weeks using the homeostatic model assessment (HOMA2-IR/IS). After 6weeks, only patients in the FMT-LF group had significant improvements in HOMA2-IR (3.16±3.01 at 6weeks versus 3.77±3.57 at baseline; P=0.02). No difference in HOMA2-IR was observed over this period for those in the FMT-HF group (3.25±1.70 at 6weeks versus 3.17±1.72 at baseline; P=0.8), the HF group (3.49±1.43 at 6weeks versus 3.26±1.33 at baseline; P=0.8) or the LF group (3.76±2.01 at 6weeks versus 3.56±1.81 at baseline; P=0.8). Interventions were safe and well-tolerated with no treatment-attributed serious adverse events. We provide proof of concept for the use of a single-dose oral FMT combined with daily low-fermentable fiber supplementation to improve insulin sensitivity in patients with severe obesity and metabolic syndrome.

DOI: 10.1038/s41591-021-01399-2

Source: https://www.nature.com/articles/s41591-021-01399-2

Nature Medicine:《自然—医学》,创刊于1995年。隶属于施普林格·自然出版集团,最新IF:87.241
官方网址:https://www.nature.com/nm/
投稿链接:https://mts-nmed.nature.com/cgi-bin/main.plex


本期文章:《自然—医学》:Online/在线发表

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