Positive Outcomes of the Supplementation With Lecithin-based Delivery Form of Curcuma Longa and of Boswellia Serrata in IBS Subjects With Small Bowel Dysbiosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Evaluate the effect of Lecithin formulation on small bowel dysbiosis
研究概览
简要总结
Small bowel dysbiosis (SBD), is a frequent finding in subjects with irritable bowel syndrome (IBS). The formula-tion in sunflower lecithin (Phytosome) of Curcuma longa and Boswellia serrata demonstrated beneficial effects on intestinal microbiota. The aim of this study was to evaluate the effect of a lecithin-based delivery formulation of Curcuma longa and of Boswellia serrata extracts (CUBO), on SBD in IBS subjects.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age ranging from 18 to 70 years;
- •diagnosis of moderate IBS according to Rome IV criteria;
- •dysbiosis of the small bowel, defined by increased urinary indican values with normal values of urinary skatole;
- •evidence of abdominal bloating and abdominal pain
排除标准
- •normal values of urinary indican or increased values of urinary skatole ;
- •subjects who were already on a low FODMAP diet (LFD) or other dietary prescription, such as lactose or gluten free diet in the last 6 months;
- •insulin-dependent diabetes or seafood, nuts or soy allergies ;
- •positive history of symptomatic diverticular disease, celiac disease, inflammatory bowel disease or microscopic colitis;
- •colonic or small bowel or gallbladder surgery ;
- •severe vomiting or bloody diarrhea ;
- •liver disease (defined as altered values of liver function tests) or severe renal disease (defined as serum creatinine >1.5 mg/dL) or treatment with antibiotics, excluding those for topical use, within the last three months
结局指标
主要结局
Evaluate the effect of Lecithin formulation on small bowel dysbiosis
时间窗: from baseline to 30 days
The primary endpoint was the change of small bowel dysbiosis established by the decrease in urine indican values. The dysbiosis of the small bowel was defined by increased urinary indican values with normal values of urinary skatole. Urinary values of indican (3-indoxyl sulfate) were evaluated through a colorimetric method. Urinary indican was considered normal when the levels were lower than 10 mg/L.
次要结局
未报告次要终点