Department of Endocrinology and Nutrition, The Biomedical Research Institute of Malaga, and Platform in Nanomedicine (IBIMA-BIONAND Platform), Virgen de la Victoria University Hospital, University of Malaga, 29016 Malaga, Spain.
CIBER in Physiopathology of Obesity and Nutrition (CIBEROBN), Carlos III Health Institute, 28029 Madrid, Spain.
Nutrients. 2024 Oct 15;16(20):3491. doi: 10.3390/nu16203491.
The objective of this study was to determine the results of fecal microbiota transplantation (FMT) from healthy lean subjects in patients with type 2 diabetes (T2D); Methods: We designed a phase II, randomized, single-blind, parallel-arm clinical trial. Twenty-one subjects (12 men [57.1%] and 9 women [42.9%]), who had previously signed an informed consent were randomized to FMT from lean donors, a probiotic ( spp. ), or placebo. Mean age at baseline was 62.5 ± 5.8 years and mean body mass index (BMI) at baseline was approximately 32.4 ± 2.4 kg/m. Anthropometric measures, biochemical variables, oral glucose tolerance test (OGTT), and a stool microbiota analysis were performed (baseline, 4 and 12 weeks). The trial was conducted following the , (CPMP/ICH/135/95) and the current Spanish legislation regarding clinical trials (RD 223/2004).; Results: FMT changes occurred at the expense of the species found in the donor. No differences in weight, body mass index, HbA1c, or the results of the OGTT for glucose and insulin were found between groups after the intervention, although a decrease in uric acid was observed in the probiotic group (-0.5 mg/dL; = 0.037) and a mild increase in HbA1c in the FMT group (+0.25%; = 0.041); Conclusions: In our sample, neither FMT from healthy and lean donors nor a probiotic were effective in improving insulin sensitivity and HbA1c in patients with T2D.
本研究旨在探讨从健康瘦型供体向 2 型糖尿病（T2D）患者进行粪便微生物群移植（FMT）的效果。方法：我们设计了一项 II 期、随机、单盲、平行臂临床试验。21 名受试者（12 名男性[57.1%]和 9 名女性[42.9%]），先前已签署知情同意书，被随机分为 FMT 组（来自瘦型供体）、益生菌组（ spp.）或安慰剂组。基线时的平均年龄为 62.5±5.8 岁，基线时的平均体重指数（BMI）约为 32.4±2.4kg/m。进行了人体测量学测量、生化变量、口服葡萄糖耐量试验（OGTT）和粪便微生物群分析（基线、4 周和 12 周）。试验按照 （CPMP/ICH/135/95）和当前西班牙临床试验法规（RD 223/2004）进行。结果：FMT 的变化是以牺牲供体中发现的物种为代价的。干预后，各组之间的体重、BMI、HbA1c 或 OGTT 对葡萄糖和胰岛素的结果均无差异，但益生菌组尿酸水平下降（-0.5mg/dL； = 0.037），FMT 组 HbA1c 轻度升高（+0.25%； = 0.041）。结论：在我们的样本中，来自健康瘦型供体的 FMT 或益生菌均不能有效改善 T2D 患者的胰岛素敏感性和 HbA1c。
