Department of Nutrition, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
Trials. 2020 Apr 14;21(1):324. doi: 10.1186/s13063-020-04236-y.
The dramatic increase in the prevalence of type 2 diabetes mellitus (T2DM) is a global major challenge to health. Circulating microRNAs have been suggested as promising biomarkers for different disorders such as diabetes. Imbalances in the gut microbiome have been revealed to contribute to the progression of multiple diseases including T2DM. Recently, the consumption of probiotics and synbiotics in the treatment of various diseases has shown a substantial growth. The anti-diabetes and anti-inflammatory effects of synbiotics have been indicated, which may be due to their beneficial effects on the gut microbiome. However, further research is needed to assess the effects of synbiotics on the microbiota and their impacts on expression of microRNAs relating to T2DM. Thus, we will aim to assess the effects of synbiotics on microbiota, serum level of tumor necrosis factor-α (TNF-α), and expression of microRNA-126 and microRNA-146a in patients with T2DM.
Seventy-two patients with T2DM will be recruited in this double-blind randomized parallel placebo-controlled clinical trial. After block matching based on age and sex, participants will be randomly assigned to receive 1000 mg/day synbiotic (Familact) or placebo for 12 weeks. The microRNA-126 and microRNA-146a expression levels will be measured by real-time polymerase chain reaction and serum TNF-α level will be assessed by enzyme-linked immunosorbent assay kit at the beginning and at the end of the study. Determination of the gut microbiota will be done by quantitative polymerase chain reaction methods at baseline and at the end of the trial. Biochemical assessments (glycemic and lipid profiles) will also be conducted at onset and end of the study.
This is the first randomized controlled trial that will determine the effect of synbiotic supplementation on the gut microbiota and its probable impacts on serum levels of TNF-α and expression of related microRNAs in patients with T2DM.
Iranian Registry of Clinical Trials: IRCT20180624040228N2. Registered on 27 March 2019. http://www.irct.ir/trial/38371.
2 型糖尿病（T2DM）患病率的急剧上升是全球健康面临的重大挑战。循环 microRNAs 已被证明是多种疾病（如糖尿病）的有前途的生物标志物。肠道微生物组的失衡已被揭示可导致多种疾病的进展，包括 T2DM。最近，益生菌和合生剂在治疗各种疾病中的应用显示出了显著的增长。合生剂具有抗糖尿病和抗炎作用，这可能是由于其对肠道微生物组的有益影响。然而，需要进一步的研究来评估合生剂对微生物群的影响及其对与 T2DM 相关的 microRNAs 表达的影响。因此，我们将旨在评估合生剂对微生物群、血清肿瘤坏死因子-α（TNF-α）水平以及 microRNA-126 和 microRNA-146a 表达的影响在 T2DM 患者中。
本双盲随机平行安慰剂对照临床试验将招募 72 名 T2DM 患者。在基于年龄和性别进行分组匹配后，参与者将被随机分配接受 1000mg/天的合生剂（Familact）或安慰剂治疗 12 周。通过实时聚合酶链反应测量 microRNA-126 和 microRNA-146a 的表达水平，通过酶联免疫吸附测定试剂盒测量血清 TNF-α 水平在研究开始和结束时。在基线和试验结束时通过定量聚合酶链反应方法确定肠道微生物群。在研究开始和结束时还将进行生化评估（血糖和血脂谱）。
这是第一项随机对照试验，将确定合生剂补充对肠道微生物群的影响及其对 T2DM 患者血清 TNF-α 水平和相关 microRNAs 表达的可能影响。
伊朗临床试验注册中心：IRCT20180624040228N2。于 2019 年 3 月 27 日注册。http://www.irct.ir/trial/38371。
