NCT02731976已完成不适用
The Influence of a Short-term Gluten-free Diet on the Human Gut Microbiome
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Changes in gut microbiota composition upon gluten-free diet intervention
研究概览
简要总结
Changes in the gut microbiomes of healthy volunteers who followed a gluten-free diet (GFD) for four weeks were studied. Per participant, nine stool samples were collected: one at baseline, four during the GFD period, and four when they returned to their habitual diet. Microbiome profiles were determined using 16S rRNA sequencing and the samples were next processed for taxonomic and imputed functional composition. Additionally, participants kept a 3-day food diary and six gut health-related biomarkers were measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy participants aged >=16
排除标准
- •Known gastrointestinal disorder
- •Known food intolerance
结局指标
主要结局
Changes in gut microbiota composition upon gluten-free diet intervention
时间窗: baseline, 4 weeks gluten-free diet and 4 weeks habitual diet
次要结局
- Changes in gut associated biomarker levels: fecal calprotectin(baseline, 4 weeks gluten-free diet and 4 weeks habitual diet)
- Changes in gut associated biomarker levels: fecal chromogranin A(baseline, 4 weeks gluten-free diet and 4 weeks habitual diet)
- Changes in gut associated biomarker levels: plasma cytokines: IL-10(baseline, 4 weeks gluten-free diet and 4 weeks habitual diet)
- Changes in gut associated biomarker levels: plasma cytokines: TNFalpha(baseline, 4 weeks gluten-free diet and 4 weeks habitual diet)
- Changes in gut associated biomarker levels: fecal human beta defensin 2(baseline, 4 weeks gluten-free diet and 4 weeks habitual diet)
- Changes in gut associated biomarker levels: fecal short chain fatty acids: propionate(baseline, 4 weeks gluten-free diet and 4 weeks habitual diet)
- Changes in gut associated biomarker levels: fecal short chain fatty acids: valerate(baseline, 4 weeks gluten-free diet and 4 weeks habitual diet)
- Changes in gut associated biomarker levels: plasma cytokines: IL-8(baseline, 4 weeks gluten-free diet and 4 weeks habitual diet)
- Changes in gut associated biomarker levels: plasma cytokines: IL-12(baseline, 4 weeks gluten-free diet and 4 weeks habitual diet)
- Changes in gut associated biomarker levels: plasma cytokines: IL-1beta(baseline, 4 weeks gluten-free diet and 4 weeks habitual diet)
- Changes in gut associated biomarker levels: plasma citrulline(baseline, 4 weeks gluten-free diet and 4 weeks habitual diet)
- Changes in gut associated biomarker levels: fecal short chain fatty acids: acetate(baseline, 4 weeks gluten-free diet and 4 weeks habitual diet)
- Changes in gut associated biomarker levels: fecal short chain fatty acids: butyrate(baseline, 4 weeks gluten-free diet and 4 weeks habitual diet)
- Changes in gut associated biomarker levels: fecal short chain fatty acids: caproate(baseline, 4 weeks gluten-free diet and 4 weeks habitual diet)
- Changes in gut associated biomarker levels: plasma cytokines: IL-6(baseline, 4 weeks gluten-free diet and 4 weeks habitual diet)
研究者
研究点 (2)
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