Groele Lidia, Szajewska Hania, Szypowska Agnieszka
Department of Paediatrics, The Medical University of Warsaw, Warsaw, Poland.
BMJ Open. 2017 Oct 11;7(10):e017178. doi: 10.1136/bmjopen-2017-017178.
Recent evidence has demonstrated that, among other factors, dysbiosis (imbalances in the composition and function of the gut microbiota) may be relevant in the development of type 1 diabetes (T1D). Thus, gut microbiota may be a target for improving outcomes in subjects with T1D. The aim of the study is to examine the effects of GG and Bb12 on beta-cell function in children with newly diagnosed T1D.
A total of 96 children aged 8 to 17 years with newly diagnosed T1D, confirmed by clinical history and the presence of at least one positive autoantibody, will be enrolled in a double-blind, randomised, placebo-controlled trial in which they will receive GG and Bb12 at a dose of 10 colony-forming units or an identically appearing placebo, orally, once daily, for 6 months. The follow-up will be for 12 months. The primary outcome measures will be the area under the curve of the C-peptide level during 2-hour responses to a mixed meal.
The Bioethics Committee approved the study protocol. The findings of this trial will be submitted to a peer-reviewed paediatric journal. Abstracts will be submitted to relevant national and international conferences.
NCT03032354; Pre-results.
最近的证据表明，除其他因素外，肠道微生物群失调（肠道微生物群的组成和功能失衡）可能与1型糖尿病（T1D）的发生有关。因此，肠道微生物群可能是改善T1D患者预后的一个靶点。本研究的目的是探讨GG和Bb12对新诊断的T1D儿童β细胞功能的影响。
共有96名年龄在8至17岁、经临床病史和至少一种阳性自身抗体确诊为新诊断T1D的儿童将参加一项双盲、随机、安慰剂对照试验，他们将接受剂量为10个菌落形成单位的GG和Bb12或外观相同的安慰剂，口服，每日一次，共6个月。随访为期12个月。主要结局指标将是对混合餐2小时反应期间C肽水平曲线下面积。
生物伦理委员会批准了研究方案。本试验的结果将提交给一份同行评审的儿科杂志。摘要将提交给相关的国家和国际会议。
NCT03032354；预结果。
