Effect of Mesalazine on Low Grade Mucosal Inflammation in Irritable Bowel Syndrome. A Pilot Double Blind Placebo Controlled Study.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The primary endpoint in the study was to assess the effect of mesalazine treatment on total number of mucosal immune cells in the colonic mucosa of patients with IBS.
研究概览
简要总结
Emerging evidence indicates the presence of low-grade mucosal inflammation and its pathogenetic role in IBS. The aim of this pilot study is to provide that mesalazine treatment of IBS patients reduces low grade colonic inflammation.
详细描述
Emerging evidence indicates the presence of low-grade mucosal inflammation and its pathogenetic role in IBS. The aim of this pilot study is to provide that mesalazine treatment of IBS patients reduces low grade colonic inflammation.
This is a pilot double blind placebo controlled study.
A total of twenty patients (both males and females) will be recruited; ten will be randomly assigned to the placebo controlled arm and ten to the study medication arm.
Inclusion criteria:
- IBS patients (both males and females) with positive diagnosis based on Rome II criteria [20]
- age ≥ 18 years
- Patients capable of conforming to the study protocol;
- Patients who have given their free and informed consent
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IBS patients (both males and females) with positive diagnosis based on Rome II criteria
- •age ≥ 18 years
- •Patients capable of conforming to the study protocol;
- •Patients who have given their free and informed consent
排除标准
- •Patients with ascertained Inflammatory Bowel Diseases (Crohn disease, Diverticular disease, Ulcerative colitis, Infectious colitis, Ischemic colitis, microscopic colitis)
- •Patients with ascertained food intolerance/allergy
- •Patients with active malignancy of any type, or history of a malignancy (patients with a history of other malignancies that have been surgically removed and who have no evidence of recurrence for at least five years before study enrollment are also acceptable)
- •Presence of major abdominal surgeries
- •Ascertained hypersensitivity to the salicylates
- •Positive faecal culture for bacterial, or parasitic pathogens
- •Patients with history of clinically significant renal (creatinine ≥ 2.0 mg/dL or ≥177 μmol/L), hepatic (AST or ALT greater than three times the upper limit of normal range), cardiac, metabolic or haematological disease
- •Esophageal, gastric or duodenal ulcer within 30 days prior to randomization
- •Patients with intended or ascertained pregnancy; lactation
- •Patients who become unable to conform to protocol
- •Patients who are continuously taking laxatives
- •Patients in antibiotic therapy during the last month
- •Patients in current therapy with corticosteroids
- •Treatment with any investigational drug within the previous 30 days
- •Treatment with lactulose or with any compound that lowering the colonic pH can prevent the release of the active moiety
- •Recent history or suspicion of alcohol abuse or drug addiction
- •Any severe pathology that can interfere with the treatment or the clinical tests of the trial
- •Previous participation in this study
研究组 & 干预措施
Placebo
Placebo
干预措施: placebo (Drug)
Mesalazine
mesalazine 800 mg t.i.d.
干预措施: mesalazine (Drug)
结局指标
主要结局
The primary endpoint in the study was to assess the effect of mesalazine treatment on total number of mucosal immune cells in the colonic mucosa of patients with IBS.
时间窗: 8 weeks
次要结局
- Effect of mesalazine on: 1) mucosal immune cell subsets; 2) inflammatory mediator release from mucosal biopsies; 3) symptom relief, as detected by means of visual analogue scales.(8 weeks)