A Clinical Study To Evaluate Small Intestine Microbiome In Multiple Sclerosis (MS)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- 16s microbiome sequencing and LC-MS metabolomic analysis will be performed on these samples to compare gut microbiome and metabolite profiles of healthy control and diagnosed MS patients
研究概览
简要总结
To access the small intestinal microbiome and find abnormal microbiome/metabolome signature in luminal fluid samples from small bowel in MS compared to HC that could be used as biomarkers for MS.
详细描述
Participants will be swallowing the SIMBA capsule which allows for minimally-invasive sampling of the microbiome and metabolome deep in the small intestine. Researchers will use the capsule samples to access the small intestinal microbiome and find abnormal metabolomic signatures in luminal fluid samples from the small bowel in Multiple Sclerosis (MS) patients compared to healthy control.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 60 years inclusive.
- •Have diagnosis of Multiple Sclerosis (relapsing remitting or secondary progressive for the MS cohort) or be a healthy individual living in the same household (non-MS for the healthy control cohort)
- •No antibiotics, or colon cleanses/bowel preparation in the previous 2 weeks.
- •Written informed consent
排除标准
- •Known to have swallowing disorders
- •Known disease which, in the investigator's opinion, would lead to intestinal stricture or obstruction with a risk of capsule non-excretion (particular diseases which would be assessed on a case-by-case basis would include, achalasia, eosinophilic esophagitis, diverticulitis, Crohn's disease, Ulcerative colitis, cancer diagnosis or treatment within the past year, or previous oesophageal, gastric, small intestinal, or colonic surgery. 3) Appendectomy or cholecystectomy more than 3 months prior to enrolment are acceptable). The main deciding factor would be history of obstructive symptoms in the previous 3 months prior to entry.
- •Use of any medications in the previous week that could substantially alter gastrointestinal motor function (e.g., opioids, prokinetics, anticholinergics, laxatives), or acidity (PPI, H2RA); for both groups.
- •< 2 bowel movements per week (for both groups).
- •Risk or suspect of being pregnant
结局指标
主要结局
16s microbiome sequencing and LC-MS metabolomic analysis will be performed on these samples to compare gut microbiome and metabolite profiles of healthy control and diagnosed MS patients
时间窗: baseline
Comparison of luminal fluid samples from the small bowel of MS and healthy control participants will allow us to find abnormal metabolomic signatures which can be used as biomarkers for MS.
Comparison of blood samples from Multiple Sclerosis (MS) and healthy control participants for biomarkers of inflammation, as analysed using ELISA, protenomic methods, and commercially available assays.
时间窗: baseline
Comparison of blood samples from Multiple Sclerosis (MS) and healthy control participants will aid in quantification of markers of inflammation and markers of intestinal function.
次要结局
未报告次要终点