BackgroundFecal microbiota transplantation (FMT) is a novel treatment for inflammatory diseases. Herein, we assess its safety, efficacy, and immunological impact in patients with moderate‐to‐severe atopic dermatitis (AD).MethodsIn this randomized, double‐blind, placebo‐controlled clinical trial, we performed the efficacy and safety assessment of FMT for moderate‐to‐severe adult patients with AD. All patients received FMT or placebo once a week for 3 weeks, in addition to their standard background treatments. Patients underwent disease severity assessments at weeks 0, 1, 2, 4, 8, 12, and 16, and blood and fecal samples were collected for immunologic analysis and metagenomic shotgun sequencing, respectively. Safety was monitored throughout the trial.ResultsImprovements in eczema area and severity index (EASI) scores and percentage of patients achieving EASI 50 (50% reduction in EASI score) were greater in patients treated with FMT than in placebo‐treated patients. No serious adverse reactions occurred during the trial. FMT treatment decreased the Th2 and Th17 cell proportions among the peripheral blood mononuclear cells, and the levels of TNF‐α, and total IgE in serum. By contrast, the expression levels of IL‐12p70 and perforin on NK cells were increased. Moreover, FMT altered the abundance of species and functional pathways of the gut microbiota in the patients, especially the abundance of Megamonas funiformis and the pathway for 1,4‐dihydroxy‐6‐naphthoate biosynthesis II.ConclusionFMT was a safe and effective therapy in moderate‐to‐severe adult patients with AD; the treatment changed the gut microbiota compositions and functions.

中文翻译：

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粪便微生物群移植治疗中度至重度特应性皮炎：一项随机、双盲对照探索者试验


背景粪便微生物群移植 （FMT） 是一种治疗炎症性疾病的新型方法。在此，我们评估了其对中度至重度特应性皮炎 （AD） 患者的安全性、有效性和免疫学影响。方法在这项随机、双盲、安慰剂对照的临床试验中，我们对中度至重度成年 AD 患者进行了 FMT 的疗效和安全性评估。除了标准的背景治疗外，所有患者都接受了每周一次的 FMT 或安慰剂，持续 3 周。患者在第 0 周、第 1 周、第 2 周、第 4 周、第 8 周、第 12 周和第 16 周接受疾病严重程度评估，并分别收集血液和粪便样本用于免疫学分析和宏基因组鸟枪法测序。在整个试验过程中监测安全性。结果接受 FMT 治疗的患者湿疹面积和严重程度指数 （EASI） 评分的改善以及达到 EASI 50 （EASI 评分降低 50%）的患者百分比优于安慰剂治疗患者。试验期间未发生严重不良反应。FMT 处理降低了外周血单核细胞中 Th2 和 Th17 细胞比例，以及血清中 TNF-α 和总 IgE 的水平。相比之下，NK 细胞上 IL-12p70 和穿孔素的表达水平升高。此外，FMT 改变了患者肠道菌群的物种丰度和功能途径，尤其是 Megamonas funiformis 的丰度和 1,4-二羟基-6-萘甲酸酯生物合成途径 II.结论FMT 在中度至重度成年 AD 患者中是一种安全有效的治疗方法;治疗改变了肠道微生物群的组成和功能。