Valutazione Dell'Efficacia Di Una Preparazione Commerciale A Base Di Lactobacillus Casei Dg Nella Riduzione Della Sintomatologia Dolorosa Associata Alla Sindrome Dell' Intestino Irritabile (Sii). Studio Clinico Pilota. (Official Title in Italian Language)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Intensity of painful symptoms
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of a treatment with Lactobacillus casei DG in the reduction of the painful symptoms in patients affected by irritable bowel syndrome. After that, the secondary object is to evaluate if the reduction of painful symptoms is related to a relevant reduction of trypsin and tryptase in colonic mucosa.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •out-Patients with diagnosis of Irritable Bowel syndrome (IBS) according to Rome III Diagnostic Criteria for Functional Gastrointestinal Disorders
- •Previous colonoscopy (within 24 month prior the enrollment) with negative results
- •written informed consent
排除标准
- •systemic or topical therapy with steroids and glucocorticoids such as beclomethasone dipropionate or budesonide, ongoing or within a month prior the enrollment
- •therapy with antibiotics or probiotics, ongoing or within a month prior the enrollment
- •inflammatory bowel diseases
- •copro-paraxitological examination with positive results
- •bowel disease with infectious, actinic, endocrine or drug-related origin
- •immunodeficiency
- •diagnosis of malignant cancer within 5 years prior the enrollment
- •renal, hepatic, hematologic, cardiovascular, pulmonary, neurological, psychiatric, immunological, gastrointestinal or endocrine disorders, if found to be clinically relevant
- •any severe disease that may interfere with the treatment;
- •abuse of alcohol, drugs or medication, psychotropic drugs
- •diagnosis of dementia or other disorders that can cause a progressive deterioration of capacity of discernment or mental and physical disability which reduces the ability to follow the prescribed therapy;
- •previous participation in this study
- •pregnant or nursing (lactating) women
研究组 & 干预措施
1
Treatment with Lactobacillus casei DG (24 billion of live cells per pill) 2 pills b.i.d. for 4 weeks
干预措施: Lactobacillus casei DG (Dietary Supplement)
结局指标
主要结局
Intensity of painful symptoms
时间窗: 4 weeks
The efficacy of the treatment will be evaluated recording the intensity of the painful symptoms associated with irritable bowel syndrome for the duration of the study. The intensity of abdominal pain will be recorded daily by the patient in a diary using a semi-quantitative scale (Likert) to 6 points, from 0 (absent) to 5 (very severe).
次要结局
- Level of trypsin and tryptase in colonic mucosa(4 weeks)