NCT02144948已完成3 期
Pilot Study to Investigate the Effect of E-coli-nissle as Probiotic Adjuvant to Antidiabetic Standard Care in Patients With Diabetes Mellitus Type II
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- GWT-TUD GmbH
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Decrease in HbA1c levels
研究概览
简要总结
This is a pilot study to investigate the effect of e.-coli-nissle as supporting therapy to antidiabetic standard care in patients with diabetes mellitus type II
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diabetes mellitus type 2;
- •HbA1c >7 % (stable für 6 months, max. variation of 0,5%)
- •stable oral antidiabetic therapy for 6 months with Metformin, Vildagliptin, Gliniden or without oral Antidiabetics
- •age of 45 to <80 years (men and women)
排除标准
- •Myocardial infarction or stroke within the last 5 years
- •Therapy with acarbose
- •Acute peripheral arterial disease within the last 12 months
- •Instable metabolic situation
- •Uncontrolled hypertension
- •Body-Mass-Index ≥ 35 kg/m²
- •Daily consumption of probiotic food
- •Malignant disease within the last 5 years
- •Status post transplantation
- •Immunosuppressive therapy within the last 3 months
- •Therapy with antibiotics
- •Macroalbuminuria
- •Severe liver disease
研究组 & 干预措施
E.-coli-Nissle
Experimental
10 patients will be enrolled Intervention: E.-coli-Nissle (Mutaflor), oral suspension Dose: 1 ml / day frequency: qd
干预措施: e.-coli-nissle (Drug)
结局指标
主要结局
Decrease in HbA1c levels
时间窗: 24 weeks
次要结局
- change in insulin resistance/secretion(24 weeks)
- change in parameters of oxidative stress(24 weeks)
- change in lipid parameters(24 weeks)
- change in gastrointestinal condition(24 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
终止
不适用
Effects of Lactobacillus Reuteri in Premature InfantsPremature Infant DiseaseNCT01181791University of Miami65
已完成
不适用
Effect of a Combination of Lactase and L. Salivarius DSM 34078 in Individuals With Lactose IntoleranceLactose IntoleranceNCT06107088Novozymes A/S76
已完成
不适用
Dietary Fibre and Metabolic BenefitsGlucose ToleranceNCT03423381Lund University18
暂停
不适用
Acute Study of Effect of Ultrasound Vagus Nerve Stimulation on GlycemiaDiabetes Mellitus, Type 2NCT04094649Aucta Technologies, Inc.10
已完成
不适用
Together on Diabetes Study: Evaluation of a Pilot Diabetes Prevention and Management Program for American Indian YouthDiabetesNCT01910727Johns Hopkins Bloomberg School of Public Health506