Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Effect of a Probiotic Mixture on Signs and Symptoms of Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Change from baseline on IBS-SSS (Irritable Bowel Syndrome-Severity Scoring System) scale at 4, 8 and 12 weeks
研究概览
简要总结
The clinical trial has a randomized, double-blind and placebo-controlled design, in which the effect of a probiotic mix wants to be evaluated, with a treatment of 12 weeks, in the evolution of the symptoms of Irritable Bowel Syndrome.
The 12 weeks of the treatment are structured in four in-person visits: Visit 1 (initial; week 0), Visit 2 (halfway; week 4), Visit 3 (halfway; week 8) and Visit 4 (final; week 12).
详细描述
Below, the four visits that compose the study and what to do in each one of them are described:
Visit 1 or initial (Week 0)
With the aim of recruiting patients, all patients diagnosed with irritable bowel who go to a consultation in the participant centres shall be informed of the study. If the patient shows interest, they shall be given detailed information about the study and the implications of their participation so that they can sign the informed consent if they wish so. Before signing, the patients shall have enough time to read and consider the detailed information and ask the investigator. The process of recruitment of patients shall continue until the sample size is reached.
Once the informed consent is signed, a doctor trained for the study shall make the initial interview in which the patient is tested to meet all the criterion for inclusion and none for exclusion (see clause 5.3.) and their clinical history.
The investigator shall proceed to assign to the patient the participant number on the study and, according to a previously elaborated randomization list, they shall be assigned the treatment that they shall receive during the study.
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, Care Provider)
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
- •Aged between 18-65 years old.
- •Informed consent signed by the patient.
- •Patients with Irritable Bowel Syndrome diagnosed by Roma IV criteria
排除标准
- •Patients who took antibiotics until two weeks prior to study.
- •Patients who have taken other probiotics two months prior.
- •Patients with other intestinal inflammatory diseases.
- •Pregnant, breastfeeding or patients who do not compromise to use an efficient contraceptive method during the development of the study.
结局指标
主要结局
Change from baseline on IBS-SSS (Irritable Bowel Syndrome-Severity Scoring System) scale at 4, 8 and 12 weeks
时间窗: 12 weeks
IBS index measures the severity of the disease, wich takes into account aspects such as pain, abdominal distension, intestinal habit and quality of life of the patient with IBS Categories of severity according to punctuation on the index IBS-SSS * Mild: 75 \<175 * Moderate: 175 \<300 * Severe: \> 300
次要结局
- Change from baseline on values of hemogram to final visit(12 weeks)
- Change from baseline on values of blood glucose to final visit(12 weeks)
- Gut microbiota changes from baseline to final visit(12 weeks)
- Compliance rate at 4, 8 and 12 12 weeks(12 weeks)
- Change from baseline on IBS-QoL (Irritable Bowel Syndrome-Quality of Life) index at 4, 8 and 12 weeks(12 weeks)
- Change from baseline on values of blood potassium to final visit(12 weeks)
- Change from baseline on values of blood creatinine to final visit(12 weeks)
- Change from baseline on values of blood sodium to final visit(12 weeks)
- Change from baseline on values of blood chlorine to final visit(12 weeks)
- Change from baseline on values of blood HDL, LDL and total cholesterol to final visit(12 weeks)
- Change from baseline on values of blood triglycerides to final visit(12 weeks)
- Change from baseline on values of blood C-reactive protein to final visit(12 weeks)
- Change from baseline on values of blood gamma glutamyl transferase (GGT) to final visit(12 weeks)
- Change from baseline on values of blood glutamic pyruvic transaminase (GPT) to final visit(12 weeks)