ACTRN12615001135505招募中未知
Gut Hormone and Anti-Inflammatory Pathways Underlying Probiotic-Effects on Glycaemic Control, Gut Microbiota and Quality of Life among Type 2 Diabetes Mellitus Patients: A Study Protocol
Dr. Neoh Chin Fen0 个研究点目标入组 100 人开始时间: 2015年10月27日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •1) T2DM patients, with glycosylated hemoglobin (HbA1c) of 7% to 10%
- •2) No change in oral hypoglycaemic agents during the last 3 months
排除标准
- •1.Already on insulin or insulin analogs or maximum dose of oral hypoglycaemic agents
- •2.Regular intake of probiotics (including fermented dairy products), antacids, H2-receptor blockers, proton pump inhibitors, loperamide, corticosteroids or sex steroids
- •3.Systemic antibiotics within 1 month before inclusion
- •4.Active smokers (still smoking at least 1 cigarette for the past 6 months)
- •5.Daily alcohol consumption >30 g
- •6.Significant immunodeficiency
- •7.Liver, thyroid, kidney or cardiac valvular disorder
- •8.Chronic gastrointestinal disease
- •9.Neurological disorders (e.g. Alzheimer's disease, stroke, Parkinson disease)
- •10.Breast-feeding, pregnancy or plan to become pregnant in the next 6-12 months
- •11.Participation in another clinical trial within the last 6 months
- •12.Enduring mental health problems (e.g. schizophrenia, bipolar disorder)
- •13.Incapacity to give consent
研究者
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