Probiotic-induced Normalization of Innate Inflammation in Youth Newly Diagnosed With Type 1 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Effect of Multistrain Probiotic on Immune System Inflammation as measured by plasma transcription analysis
研究概览
简要总结
The investigators aim to further the understanding of environmental factors that underlie the development of Type 1 diabetes (T1D) and the post-onset disease trajectory. Dysbiosis, defined as alterations in intestinal microbiota composition and function, has been hypothesized to increase the risk of developing T1D in those with genetic susceptibility. Dysbiosis may result from modern dietary habits, such as broad consumption of the highly processed Western Diet, or by widespread use of antibiotics. Here, the investigators propose to examine the impact of dysbiosis on the endogenous innate inflammatory state that potentiates T1D progression. The investigators hypothesize that probiotic-induced alterations in the intestinal microbiota may favorably alter the post-onset disease state.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must meet all of the following criteria:
- •Males and females 5-17 years of age with a clinical diagnosis of T1D within the past 90 days
- •Positive for ≥ 1 diabetes-related autoantibodies (IAA, GAD, IA-2, or ZnT8)
- •Stimulated C-peptide area under the curve (AUC) of ≥ 0.2 nmol/L during a mixed meal tolerance test
- •Treatment naïve of any immunomodulatory agent
排除标准
- •Patients must NOT meet any of the following criteria:
- •Probiotic use within 1 month of screening visit
- •Presence of severe, active disease that requires the use of chronic medication, with the exception of well-controlled autoimmune thyroiditis/hypothyroidism
- •Diabetes other than T1D
- •Female participants of child-bearing age with reproductive potential must not be knowingly pregnant
- •Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results
结局指标
主要结局
Effect of Multistrain Probiotic on Immune System Inflammation as measured by plasma transcription analysis
时间窗: 3 years (duration of study)
Investigators will examine the effect of multistrain probiotic supplementation on the endogenous innate inflammatory state in youth newly diagnosed with T1D, as measured by plasma-induced transcription analysis. The investigators hypothesize that the participants receiving the probiotic will have less inflammation (as measured by transcriptional analysis) than the participants in the placebo group.
次要结局
- Effect of Multistrain Probiotic on broader Immune System Effects as measured by plasma-induced transcriptional analyses(3 years (duration of study))
- Changes to intestinal bacteria as measured by stool analysis(3 years (duration of study))
- C-peptide decline(3 years (duration of study))
- Cytokine Levels (a measure of inflammation) as measured by plasma analysis(3 years (duration of study))
- System-wide Effects as measured by systemic microbial antigen (a marker of intestinal permeability) as measured by plasma analysis(3 years (duration of study))
研究者
Susanne Cabrera
Principal Investigator
Medical College of Wisconsin