Effect of Daily Consumption of Glycomacropeptide on Gut Microbiome and Blood Functional Proteome of Subjects With Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Measure the inflammatory markers in stool and blood using immunology multiplex assay
研究概览
简要总结
This study investigates the use of glycomacropeptide (GMP) as a means to manipulate the gut microbiome, metabolome and protein profile of subjects with irritable bowel syndrome (IBS).
详细描述
In vitro assays show that GMP strongly promotes the growth of beneficial bacteria including Bifidobacterium breve, B. bifidum, B. infantis and Lactococcus lactis. GMP also binds to pathogenic bacteria and prevents their adhesion to intestinal cells, which could prevent enteric infection. GMP also modulates the inflammatory response of key gut immune cells called macrophages. However, the extent to which daily consumption of GMP alters the gut microbiome, metabolome and protein profile of subjects with IBS remains unknown.
This study will investigate how daily GMP consumption can alter the gut microbiome, metabolome and protein profile of subjects with IBS.
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
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fluent in English
- •IBS diagnosis with Rome IV criteria
- •People who have a primary care provider
排除标准
- •Lactose or milk protein intolerance
- •Any known other gastrointestinal disease or disorder beyond IBS, or major gastrointestinal surgery
- •Habitual use of laxatives or antacids
- •Pregnant or nursing.
- •Use of pre or probiotics within one month prior to the study
- •Use of antibiotics within one month prior to the study
结局指标
主要结局
Measure the inflammatory markers in stool and blood using immunology multiplex assay
时间窗: Baseline, GMP feeding week 1, 2 and 3 and post study without GMP feeding week 1, 2 and 3
Change in levels of inflammatory markers (GM-CSF, IFN-γ, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-9, IL-10, IL-12 (p70), IL-13, IL-15, IL-17A, IL-17F, IL-17E/IL-25, IL-21, IL-22, IL-23, IL-27, IL-28A, IL-31, IL-33, MIP-3α/CCL20, TNF-α and TNFβ) in stool and blood using immunology multiplex assay
Stool sample based gut microbiome composition using 16S rRNA gene sequencing
时间窗: Baseline, GMP feeding week 1, 2 and 3 and post study without GMP feeding week 1, 2 and 3
Change in stool sample based gut microbiome composition using 16S rRNA gene sequencing.
次要结局
未报告次要终点
研究者
Dave Dallas
Assistant Professor
Oregon State University