Effect of Pentoxifylline on Tight Junctions of Intestinal Mucosa in Patients With Irritable Bowel Syndrome
试验速览
- 阶段
- 4 期
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Severity of abdominal pain
研究概览
简要总结
The purpose of this study is to determine the therapeutics effectiveness of oral pentoxifylline treatment in patients with IBS.
详细描述
Disruption of the intestinal epithelial barrier is part of the pathophysiology of IBS favoring immune activation present in the mucosa of these patients and the development of symptoms in IBS. To evaluate the effect of treatment with pentoxifylline (PTX) in patients with IBS related to clinical response and modulation of the components of the epithelial barrier at the level of intestinal mucosa.
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
- Double (Participant, Investigator)
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
- •Age between 18 and 65 years old
- •Most of the patient with IBS will be chose between the patients who go to Digestive System ambulatory external medical office from our Center.
- •Be studied and with clinical monitoring al least 6 months before be included.
- •Fulfill with Roma III Criteria for IBS (Gastroenterology 2006;130:1377-90) with moderate-severe seriousness according to Modification Francis Scale
排除标准
- •2 weeks before colon biopsia, any patient cann´t take salicylates, NSAID, antibiotics,anticholinergics,opiates or any other medication / product for asintomatic treatment of diarrea.
- •3 months before colon biopsia, any patient cann´t take medicaments as corticoides, antihistamines or immunosuppressive
- •6 months before colon biopsia, any patient cann´t recive radiotherapy or chemotherapy.
- •Pentoxifilina Alergic Reactions
- •Pregnants
- •Grave kidney failure
- •Grave Hepatic failure
- •Menthal or legal disability to sign the consent
研究组 & 干预措施
pentoxifylline
干预措施: pentoxifylline (Drug)
pentoxifylline placebo
干预措施: pentoxifylline placebo (Drug)
结局指标
主要结局
Severity of abdominal pain
时间窗: 3 months from the first day of treatment
Clinical endpoint: Average daily severity of abdominal pain on a 0-10 scale \[ Time Frame: Week 0 to week 12 \] \[ Designated as safety issue: No \] Days with urgency \[ Time Frame: Week 0 to week 12 \] \[ Designated as safety issue: No \] Mean stool consistency using Bristol Stool Form Score \[ Time Frame: Week 0 to week 12 \] \[ Designated as safety issue: No \] Global satisfaction with control of IBS symptoms as assessed from the answer to the question "Have you had satisfactory relief of your IBS symptoms this week? Yes / No. "
次要结局
- Mucosal byopsies(3 months from the first day of treatment)