Association Between High Faecal Calprotectin, Increased Intestinal Permeability and Visceral Hypersensitivity in Patients Suffering From Irritable Bowel Syndrome With Diarrhoea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Occludin level expression in left colonic biopsies
研究概览
简要总结
Visceral hypersensitivity, low grade inflammation and increased intestinal permeability are three main pathophysiological mechanisms involved in irritable bowel syndrome. The connexion between these abnormalities is not known. We hypothesis there is a link between them in IBS with diarrhoea.
详细描述
Irritable bowel syndrome (IBS) is a common functional disorder which affect around 10% of the general population. Abdominal pain and discomfort are associated with transit disorders (diarrhea, constipation, alternating). IBS is defined by Rome III criteria.
For clinicians, IBS remains difficult to treat while its pathophysiology remains not completely understood. Visceral hypersensitivity, low grade inflammation and increased intestinal permeability are three abnormalities found in IBS patients. Visceral hypersensitivity is present in 60% of the patients, while intestinal permeability is increased in a subgroup of IBS with diarrhea. Low grade inflammation could be identify with faecal calprotectin dosage. The link between this three abnormalities is not clear.
The goal of our study is to describe the prevalence of these three abnormalities in IBS-Diarrhea population and to look for a correlation between low grade inflammation, visceral hypersensitivity, increased intestinal permeability and clinical phenotypes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- •IBS-Diarrhoea according to Rome III criteria,
- •Faecal calprotectin ≤200 µg/g in the last two months
- •Effective contraception since 1 month for women in childbearing age
排除标准
- •Patients with organic and/or inflammatory digestive disease
- •IBS with constipation or alternating
- •Treatment such as anti-inflammatory, probiotic in the last three months
- •Patient with blood dyscrasia disorder known or identified , anticoagulant or antiplatelet treatments
- •Small intestinal bacterial overgrowth (identified by a glucose breath test)
- •Hypersensitivity to Normacol
- •Severe renal failure
- •Anal pathology (anal fissure, hemorrhoidal thrombosis)
- •Pregnant or breastfeeding women
- •Person with administrative or judicial decision or under legal protection measure
- •Patient participating in another trial in the last two weeks
- •Diet based in grapes
结局指标
主要结局
Occludin level expression in left colonic biopsies
时间窗: day 1
Occludin expression is measured using western blot (for proteins), Quantitative Real Time Polymerase Chain Reaction (q RT-PCR) (RNA) and IF (for localization)
Faecal calprotectin level
时间窗: day 1
Level is assessed on stool sample by ELISA kit in µg/g
次要结局
- Zonula Occludens (ZO)-1 level expression(day 1)
- Claudin level expression in left colonic biopsies(day 1)
- Pression pain threshold by rectal barostat(day 1)
- Quality of life by GIQLI(day 1)
- Abdominal symptoms(day 1)
- Anxiety and depression level(day 1)