Palacios Talia, Vitetta Luis, Coulson Samantha, Madigan Claire D, Denyer Gareth S, Caterson Ian D
The Boden Institute of Obesity, Nutrition, Exercise and Eating Disorders, University of Sydney, Sydney, Australia.
University of Sydney, Sydney Medical School, Sydney, Australia.
Trials. 2017 Jan 9;18(1):7. doi: 10.1186/s13063-016-1762-x.
Shifts in the gastrointestinal microbiome have been shown to contribute to the progression of metabolic diseases including prediabetes and type 2 diabetes mellitus. Research suggests that in-vivo modulation of the gut microbiome by specific probiotic microorganisms may improve insulin sensitivity and blood sugar management, preventing or delaying the development of type 2 diabetes mellitus. However, further research is needed to understand the effect of probiotics as a therapy for the treatment of metabolic diseases. An evidence-based multi-species probiotic was developed to encourage a shift in the gastrointestinal bacterial cohort from a disease-prone to a balanced state with the aim of improving metabolic markers associated with type 2 diabetes mellitus.
Sixty adults with a body mass index ≥25 kg/m with prediabetes or type 2 diabetes mellitus (diagnosed within the previous 12 months) will be enrolled in a double-blind, placebo-controlled pilot study. Participants will be randomized to a multi-species probiotic or placebo for 12 weeks. Both groups will receive lifestyle and nutritional advice. The primary outcome measure is the change between groups in fasting plasma glucose levels from baseline to 12 weeks. Secondary outcome measures include, but are not limited to, the change in lipid profile, systemic inflammation, gut permeability, and faecal microbial and metabolomic profiles. Blood and stool samples are collected at baseline and 12 weeks after treatment.
Intentional manipulation of gastrointestinal microbial profiles may be useful for preventing and controlling type 2 diabetes mellitus and its associated metabolic complications.
Australian New Zealand Clinical Trials Registry, ACTRN12613001378718 . Registered on 16 December 2013.
胃肠道微生物群的变化已被证明会促进包括糖尿病前期和2型糖尿病在内的代谢性疾病的发展。研究表明，特定益生菌微生物对肠道微生物群的体内调节可能会改善胰岛素敏感性和血糖管理，预防或延缓2型糖尿病的发展。然而，需要进一步研究以了解益生菌作为治疗代谢性疾病的疗法的效果。开发了一种基于证据的多物种益生菌，以促使胃肠道细菌群从易患疾病状态转变为平衡状态，目的是改善与2型糖尿病相关的代谢指标。
60名体重指数≥25kg/m²且患有糖尿病前期或2型糖尿病（在过去12个月内确诊）的成年人将参加一项双盲、安慰剂对照的试点研究。参与者将被随机分为多物种益生菌组或安慰剂组，为期12周。两组都将接受生活方式和营养建议。主要结局指标是两组从基线到12周空腹血糖水平的变化。次要结局指标包括但不限于血脂谱、全身炎症、肠道通透性以及粪便微生物和代谢组学谱的变化。在基线和治疗后12周采集血液和粪便样本。
有意操纵胃肠道微生物谱可能有助于预防和控制2型糖尿病及其相关的代谢并发症。
澳大利亚新西兰临床试验注册中心，ACTRN12613001378718。于2013年12月16日注册。
