Evaluation of the Effectiveness of a Physical Exercise Intervention on Quality of Life and Symptom Profile of Patients With Irritable Bowel Syndrome (IBS).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 137
- 试验地点
- 1
- 主要终点
- Symptom assessment
研究概览
简要总结
Specific Aim 1: As shown in the literature, exercise can be a useful tool for treating and improving functional GI disorders. Therefore, the aim is to estimate the effectiveness of an exercise intervention on IBS symptoms as measured by a reduction of at least 50 score points on the IBS- Symptom Severity Scale (IBS-SSS) questionnaire.
详细描述
Inclusion criteria:
Adult patients (18-65 years old) referred to the "Outpatient Clinic for Celiac Disease and Functional Disorders" who met the Rome III-IV criteria for IBS-D and were referred by their local General Practitioner.
Exclusion criteria:
Presence of severe heart, liver, neurological or psychiatric disease or GI disease other than IBS (e.g., inflammatory bowel disease, celiac disease) that could explain the current symptoms.
Patients who have previously followed a diet low in particular substances (e.g., low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols - FODMAP -) diet, vegan diet, a gluten-free diet).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients referred to the "Outpatient Clinic for Celiac Disease and Functional Disorders" who meet the Rome III-IV criteria for IBS-D and referred by their local General Practitioner.
排除标准
- •Presence of severe heart, liver, neurological or psychiatric disease or GI disease other than IBS (e.g., inflammatory bowel disease, celiac disease) that could explain the current symptoms.
- •Patients who have previously followed a diet low in particular substances (e.g., low FODMAPs, vegan diet, gluten-free diet).
- •Antidepressant use
结局指标
主要结局
Symptom assessment
时间窗: Baseline and after 3 months
To evaluate the effectiveness of an exercise intervention on IBS symptoms as measured by a change in the IBS-Symptom Severity Scale (IBS-SSS) questionnaire score from baseline. The IBS-SSS is a validated questionnaire for gastrointestinal symptoms and provides a global measure of symptom severity by assessing five items ("severity of abdominal pain", "frequency of abdominal pain", "severity of abdominal distension", "dissatisfaction with bowel habits", "impact of symptoms on quality of life") on a visual analogue scale. The values of the five items are added together to give a total score between 0 and 500. Cases are then classified as 'mild' (75 to 175), 'moderate' (175 to 300) and 'severe' (\>300).
次要结局
- Gatroduodenal permeability(Baseline and after 3 months)
- Intestinal microbiota analysis(Baseline and after 3 months)
- Evaluation of Barrier peptide integrity(Baseline and after 3 months)
研究者
Alberto R Osella
Principal Investigator
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis