Pilot Study of Probiotics in Pre-diabetic Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Change in microbiota composition
研究概览
简要总结
This study evaluates the feasibility and effect of probiotics on glycemic control in obese adolescents.
详细描述
Diet-induced intestinal dysbiosis in obese children contributes to the development of type 2 diabetes mellitus (T2D). Probiotic treatment has been proposed to alleviate glycemic dysfunction and prevent/delay development of T2D. The investigators will test probiotics to improve insulin sensitivity and preserve beta cell function in obese children.
The probiotic strains are known to improve glycemic control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
The study product will be prepackaged and will be supplied and labeled only with the Protocol Number.
入排标准
- 年龄范围
- 13 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, 13-19 y. of age at Visit
- •BMI: 99th percentile or greater
- •Acanthosis nigricans
- •Pubertal Tanner stage ≥3
排除标准
- •Secondary diabetes (i.e. post-transplant diabetes mellitus (DM) or cystic fibrosis DM), monogenic forms of diabetes (i.e. MODY), autoimmune diabetes or presence of islet autoantibodies.
- •Known severe immunodeficiency, or immune compromised.
- •Current or previous history for insulin or metformin therapy (within last 3 months).
- •Antibiotic or probiotic therapy 3 months prior to enrollment.
- •Start of new dietary intervention within 1 month prior to enrollment.
- •Diagnosed food hypersensitivity or active gastrointestinal disease
结局指标
主要结局
Change in microbiota composition
时间窗: Baseline and 12 weeks
Microbiome (16S rRNA) analysis, fecal immunoglobulin (Ig)A
次要结局
- Change in insulin resistance(baseline and 12 weeks)
- Change in inflammation in blood(baseline and 12 weeks)
- Change in inflammation in the gut(baseline and 12 weeks)
研究者
Christian L Roth, MD
Professor
Seattle Children's Hospital