Evaluation Study of the Intestinal Microbiota and Quality of Life in Patients Suffering From Irritable Bowel Syndrome Treated With Bifidice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Modification of teh intestinal microbiota
研究概览
简要总结
Irritable bowel syndrome is the most common functional gastrointestinal disease and is characterized by high prevalence and chronic course.The pathology has a strong impact on the quality of life of affected patients and on health and social costs, these related to reduced productivity.The scarce efficacy and heavy side effects of traditional therapies lead these patients to often resort to alternative or complementary therapies. From the evaluation of the evidence of various probiotic preparations and food supplements, the investigators have used a commercial preparation characterized by the presence of bifidobacteria which have demonstrated some efficacy in thinking of improving the quality of life of these patients to evaluate quality of life, ability productivity and trend of some indices of disease severity in a small number of patients. These preliminary data could represent a starting point for more in-depth evaluations, also with placebo-controlled studies.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥18 years
- •Diagnosis of IBS according to Rome IV criteria
- •Mild to moderate disease, as measured by FBDSI
- •Absence of signs and symptoms that may suggest organic damage and, if indicated, negative instrumental investigations (colonoscopy and/or imaging)
- •Prescription of Bifidice, according to normal clinical practice
- •Informed consent expressed in written form
排除标准
- •Patients undergoing surgical resection of the stomach, gallbladder, small or large intestine
- •History of inflammatory bowel disease
- •Severe SII, measured by FBDSI
- •Active peptic ulcer
- •History of ischemic colitis
- •Active infectious enteritis
- •Diagnosed with hypo- or hyperthyroidism
- •Need for pharmacological treatments for IBS, antibiotics, antidepressants and laxatives
- •Therapy in progress with drug or supplements included in the list of those not allowed (Paragraph N: to be established)
- •Any disease that may affect gastrointestinal function and could interfere with appropriate assessment of abdominal pain or discomfort
研究组 & 干预措施
Probiotic
Probiotic
干预措施: Probiotic Formula (Drug)
结局指标
主要结局
Modification of teh intestinal microbiota
时间窗: 12 months
Analysis of faecal samples (Next Generation Sequencing analysis)
次要结局
未报告次要终点