Effects of Low FODMAP Diet on Leaky Gut and Mucosal Immune Cell Abundance in Diarrhea-predominant Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 4
- 主要终点
- colonic permeability
研究概览
简要总结
The pathophysiology of Irritable bowel syndrome (IBS) is multifactorial involving complex interplay of altered intestinal permeability, mucosal immune activation, visceral hypersensitivity and gut dysbiosis. Although the exact triggers for these pathological changes in IBS are not clear but diet might play an important role. In fact, several studies have reported improvement in gastrointestinal symptoms on a diet low in FODMAPs (LFD) in patients with IBS, specifically in diarrhea predominant IBS (IBS-D). However, the mechanism of action of LFD is not well understood.
详细描述
we aim to evaluate the following in patients with IBS-D. The effect of LFD on colonic permeability. 2.The effect of LFD on abundance of colonic mucosal immune cells specifically T-cell and mast cell abundance 3.The effect of LFD on colonic mucosal microbiome
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18-65 years at the time of screening
- •normal serum studies including serum tissue-transglutaminase antibodies, thyroid stimulating hormone levels, C-reactive protein, complete blood count since the onset of symptoms
- •normal stool studies including C diff testing, culture, ova and parasites since the onset of symptoms
- •IBS-SSS score of ≥175 at the end of 7-day screening period
- •Exclusion criteria:
- •individuals already on a LFD or other dietary restriction such as gluten free diet within the past 6 months
- •individuals with any known food allergy or insulin-dependent diabetes
- •known history of celiac disease, inflammatory bowel disease or microscopic colitis
- •prior small bowel or colonic surgery or cholecystectomy
- •pregnant patients
- •antibiotics in the past 3 months
- •those who regularly use mast cell stabilizers or anti-histaminic or non-steroidal anti-inflammatory agents (NSAIDs) excluding daily baby aspirin or steroids or bile-acid binder.
排除标准
- 未提供
结局指标
主要结局
colonic permeability
时间窗: 4 weeks
Lactulose:Mannitol ratio pre and post treatment
次要结局
- colonic immune cells(4 weeks)
- colonic microbiome(4 weeks)
研究者
Judy Nee
Assistant Professor of Medicine
Beth Israel Deaconess Medical Center