Effects of a Combination of Polyphenol-rich Extracts, Prebiotics, and Hydrolyzed Fiber on the Quality of Life of Patients With Irritable Bowel Syndrome (IBS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Stool consistency
研究概览
简要总结
The aim of the study is to demonstrate a beneficial effect in reducing symptoms that negatively affect the quality of life of IBS patients, and to demonstrate a positive effect on inflammatory and intestinal function markers.
详细描述
The double-blind, randomized, placebo-controlled study will be conducted on 48 patients (18-55 years old) with Irritable Bowel Syndrome (IBS). The study will consist of 2 months of supplementation with three parallel arms: 1) probiotic strains and prebiotic (Partially Hydrolyzed Guar Gum); 2) probiotic strains, prebiotic (Partially Hydrolyzed Guar Gum) and elderberry and chokeberry fruit extract; 3) placebo.The study will assess symptoms associated with IBS, using the IBS-QOL questionnaire and the Bristol Stool Formation Scale. Markers of inflammation and intestinal barrier permeability , will be determined in blood and stool samples collected from patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed Irritable Bowel Syndrome.
- •Women and men, 18-55 years old.
- •Signed informed consent.
排除标准
- •Intake of supplements containing plant extracts, polyphenols or anthocyanins, and supplements containing fiber, probiotics and prebiotics.
- •Participation in another clinical trial.
- •Inability to swallow an oral study drug/placebo.
- •Oncological disease, autoimmune disease, severe liver dysfunction, tuberculosis, leukemia, multiple sclerosis, AIDS, rheumatoid arthritis, organ transplant and other gastrointestinal diseases that may affect the results of the study.
- •Women who are pregnant, planning to become pregnant during the study, or breastfeeding,
结局指标
主要结局
Stool consistency
时间窗: Baseline, 2 months
Will be assessed using the Bristol Stool Chart
IBS-QoL (Irritable Bowel Syndrome-Quality of Life) index
时间窗: Baseline, 2 months
IBS-QoL measures the impact of the disease on the quality of life of patients with IBS
次要结局
- I-FABP(Baseline, 2 months)
- IL-6(Baseline, 2 months)
- IL-8(Baseline, 2 months)
- Zonulin(Baseline, 2 months)
- Short-chain fatty acids(Baseline, 2 months)