Effects of a Food Supplement Composed by BIOintestil ® (Bionocol®) on Microbiota and Inflammatory Profile in Irritable Bowel Syndrome Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Changes in fecal Microbiota composition
研究概览
简要总结
The aim of this double blind placebo-controlled study is to evaluate the effect of BIOintestil on fecal microbiota, inflammatory chemokines and symptoms in patients affected by Irritable Bowel Syndrome (IBS).
详细描述
BIOintestil is a dietary supplement based on Palmrose oil (Cymbopogon martinii) and ginger ryzoma powder. Palmrose oil effects were already established in animal model of colitis and in a pilot study on patients with IBS. In this study, 108 patients will be randomized to receive BIOintestil or placebo in a 1:1 ratio, for four weeks. Fecal and blood samples will be collected at each visit for microbiota and chemokine analysis, patients syntoms will be evaluated by administration of the validated IBS-VAS.
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
- •willing of sign written informed consent;
- •participants affected with Irritable bowel syndrome (IBS) who satisfy Rome III criterias for diagnosis
- •body weight between 48 and 104 kg, with a BMI less than 27
- •age between 18 and 65 years old
排除标准
- •participants that have not taken following medications within 30 days before randomization: steroidal anti-inflammatory drugs, antibiotics or supplemntes or functional foods that may contain probiotics or prebiotics
- •women who suspect to be/are pregnant or in lactacy
- •participants with Inflammatory bowel disease disgnosis or celiac disease or severe systemic disease
- •participants who are intolerant to lactose or with food allergies confirmed
- •particpiants with confirmed or suspected hypersensibility to one or more of Bionocol® components
- •participants with severe concomitants disease that, by investigator's opinion, interfere with study partecipation
- •participants under anticoagulant therapy or with coagulation disease
- •participants with renal and hepatic failure
- •participants who have taken any investigational drug within 2 month the randomization visit
结局指标
主要结局
Changes in fecal Microbiota composition
时间窗: 4 weeks
relative abundance of bacteroidetes
次要结局
- Changes in circulating cytokines and chemokines(4 weeks)
- Irritable Bowel Syndrome-Visual Analogue Scale (IBS-VAS) score improvement(4 weeks)