Confocal Endomicroscopy Utility for Diagnosing Mucosa Micro-inflammation in Patients With Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Confocal Laser Endomicroscopy (CLE) utility for diagnosing microscopic inflammation of the mucosa in patients with irritable bowel syndrome (IBS)
研究概览
简要总结
Irritable bowel syndrome (IBS) is one of the most common gastrointestinal disorders. It has prevalence in general population of 5-20% and is more common in women and young adults.
Despite being one of the most frequent reasons for consultation many patients are undiagnosed. There are no reliable biomarkers. The diagnosis is clinical, based on the Rome III criteria. IBS is characterized by chronic or recurrent abdominal pain associated with changes in bowel frequency and consistency, when other etiologies are excluded. The combination of the Rome III criteria with the absence of alarm symptoms have a sensitivity of 65%, specificity of 100%, 100% positive predictive value and negative predictive value of 76%.
Current tests commonly fail to obtain an objective diagnosis, and effective therapies are lacking. There are no specific endoscopic findings that can discriminate IBS patients from healthy patients. Most colonoscopies are performed to rule out other etiologies and in more than 50% of the cases are normal.
详细描述
The pathophysiology is complex, multifactorial and not completely known. Impaired intestinal barrier function and mucosal inflammation in the small and large intestine have been reported. Evidence of inflammation and neuronal degeneration in the myenteric plexus has been found in full-thickness intestinal biopsy samples from IBS patients.
It has been found that IBS patients had a significantly higher density of intestinal epithelial gaps. The elevated epithelial gaps in the intestine of IBS patients, a surrogate marker for increased epithelial cell extrusion, may be a cause of altered intestinal permeability observed and may lead to mucosal inflammation.
Confocal laser endomicroscopy (CLE) is a new endoscopic imaging tool enabling visualization of changes in the gut mucosa. The use of intravenous fluorescein enables high-resolution real-time imaging in vivo at a micron scale, allowing visualization of cellular details during ongoing endoscopy. This technology can be used to identify and quantify epithelial gaps and other signs of inflammation.
The purpose of this study is to evaluate the presence of microscopic inflammation previously demonstrated in patients with IBS, using pCLE. The determination of the exact areas of inflammation allows a direct biopsy in a more accurate way. This type of systematic may allow in the future to classify these patients not only symptomatically (constipation, diarrhea or mixed predominant IBS) but also according to their degree of inflammation. There is no Gold Standard test in these patients to assess response to treatment. The possibility of using pCLE to identify the areas of microscopic inflammation allows that the degree of inflammation can be used as a monitoring parameter. Probably the CLE can be used to assess response to treatment and different types of treatments, determining differences between subtypes of patients with IBS, evaluate remission, recurrence and prognosis. Also it may clarify a potential mechanism of the pathogenesis and be endoscopic criteria for the diagnosis of the disease.
The present study is the first to evaluate the colon microscopic inflammation using pCLE in IBS patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
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
- 否
入选标准
- •Above 18 years old patients
- •Who agree to participate in the study
- •Ability to provide written informed consent
- •Patients with irritable bowel syndrome according to Roma III classification.
排除标准
- •Patients, who were receiving nonsteroidal anti-inflammatory drugs, corticosteroids or antibiotics in the last 4 weeks.
- •Patients with heart disease, kidney, liver or severe metabolic disorder, who cannot tolerate sedation
- •Inflammatory bowel disease
- •Bacterial overgrowth
- •Gastrointestinal bleeding
- •Prior history of any king of colitis (actinic, infectious, ischemic, microscopic colitis)
- •Suspected colonic obstruction or history of previous obstruction
- •Prior history of colectomy surgery
- •Patients with an ileostomy or a colostomy
- •Patients with difficulty understanding instructions of bowel preparation
- •Known allergy to fluorescein or shellfish
- •Pregnancy and lactation
- •Bowel preparation will be evaluated using the Boston Bowel Preparation Scale. (9) Patients with < 2 points in at least one of the three segments of the colon (rectum plus left-side colon, transverse colon plus left and right flexure, right-side colon) will be excluded from statistical analysis as well as those who after the beginning of the colonoscopy, had to be aborted because of an inability to reach the cecum by unfavorable anatomy or impassable tumors / stenosis.
结局指标
主要结局
Confocal Laser Endomicroscopy (CLE) utility for diagnosing microscopic inflammation of the mucosa in patients with irritable bowel syndrome (IBS)
时间窗: four month
Number of patients with IBS and microscopic inflammation determinate by CLE
次要结局
- Relationship between microscopic inflammation and sex, age and the subtypes of IBS.(four month)