Effects of Low FODMAP Diet on Colonic Epithelial Physiology in Diarrhea-predominant Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Lactulose Mannitol Excretion
研究概览
简要总结
This research is studying whether changing an individual's diet may have an impact as a treatment or outcome for Irritable Bowel Syndrome (IBS). This research will show if diet might play a role in triggering changes that may cause IBS. This study is being done to learn if a low FODMAP (fermentable, oligosaccharides, disaccharides, monosaccharides, and polyols) diet causes changes in the colon lining which mediates improvement in IBS symptoms.
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
- •Normal serum studies including serum tissue-transglutaminase antibodies, thyroid stimulating hormone levels, C-reactive protein or fecal calprotectin, complete blood count since the onset of symptoms.
- •Normal stool studies including, ova and parasites since the onset of symptoms
- •IBS-SSS score of ≥175 at the end of the 7-day screening period
- •In case of presence of any alarm features and/or elevated inflammatory markers (C-reactive protein or fecal calprotectin), patients will be eligible if they have been excluded for inflammatory bowel disease with colonoscopy in the last one year.
排除标准
- •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.
研究组 & 干预措施
Study patients with IBS-D
Patients with diarrhea-predominant IBS who will undergo a low FODMAP diet for 4 weeks
干预措施: a low FODMAP diet for 4 weeks (Other)
结局指标
主要结局
Lactulose Mannitol Excretion
时间窗: 4 weeks
Changes in cumulative excretion of lactulose and mannitol in timed urine collection before and after low FODMAP diet measured during 8-24h
次要结局
- Changes in Epithelial Permeability - Quantitative Tight Junction Immunostaining(4 weeks)
- Gastrointestinal Patient Reported Outcomes Measurement Information System (PROMIS)(4 weeks)
- Changes in Stool Microbiome - Alpha Diversity(4 weeks)
- Immunohistochemistry for Mast Cells(4 weeks)
- Changes in Epithelial Permeability - Tight Junction Gene Expression(4 weeks)
- Changes in Stool Microbiome - Beta Diversity(4 weeks)
研究者
Prashant Singh
Assistant Professor
University of Michigan