Efficacy and Safety of Saccharomyces Boulardii CNCM I-745 in the Treatment of Small Intestinal Bacterial Overgrowth in Patients Suffering From Irritable Bowel Syndrome With Diarrhea
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Change in symptom severity measured by the Irritable Bowel Syndrome Symptom Severity Scale
研究概览
简要总结
Non-constipated irritable bowel syndrome is a common disorder that may be related to small intestinal bacterial overgrowth. Saccharomyces boulardii CNCM I-745 is a probiotic yeast that has proven efficacy for the treatment of acute gastroenteritis and antibiotic-associated diarrhea. However, its efficacy for the treatment of diarrhea-predominant irritable bowel syndrome with small intestinal bacterial overgrowth has not been assessed. Hence, an exploratory randomized, open label trial comparing the efficacy and safety of Saccharomyes boulardii CNCM I-745 plus diet administration versus diet administration only for 15 days among adult patients with the aforementioned condition was conducted.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients
- •Diagnosis of Irritable Bowel syndrome according to Rome III criteria
- •Diagnosis of concomitant small intestinal bacterial overgorwth (SIBO) by breath test
排除标准
- •Pregnancy
- •Diagnosis of Celiac disease
- •Diagnosis of Inflammatory Bowel Disease or other immune-mediated gastrointestinal conditions
- •Immunosuppression
- •Diagnosis of active cancer
研究组 & 干预措施
Dietary advice without medication
Patients received dietary advice for 15 days. Dietary advice consisted of a low fermentation diet which was delivered as a written list of food and beverages that patients should avoid adapted to local habits and an oral explanation by a health professional.
干预措施: Dietary advice following a low fermentation diet (Behavioral)
Saccharomyces boulardii (1 capsule of 250 ug BID) + Dietary advice
Patients received 1 capsule of Saccharomyces boulardii 250 ug BID plus dietary advice for 15 days. Dietary advice consisted of a low fermentation diet which was delivered as a written list of food and beverages that patients should avoid adapted to local habits and an oral explanation by a health professional.
干预措施: Saccharomyces Boulardii 250 MG (Drug)
Saccharomyces boulardii (1 capsule of 250 ug BID) + Dietary advice
Patients received 1 capsule of Saccharomyces boulardii 250 ug BID plus dietary advice for 15 days. Dietary advice consisted of a low fermentation diet which was delivered as a written list of food and beverages that patients should avoid adapted to local habits and an oral explanation by a health professional.
干预措施: Dietary advice following a low fermentation diet (Behavioral)
结局指标
主要结局
Change in symptom severity measured by the Irritable Bowel Syndrome Symptom Severity Scale
时间窗: 15 days
The IBS Symptom Severity Scale (IBS-SSS) is a validated questionnaire (Francis et al. 1997) that evaluates the intensity of the following IBS symptoms: abdominal pain, distension, stool frequency and consistency, and general impact on life. The IBS-SSS calculates the sum of these 5 items (each scored on a visual analogue scale from 0 to 100) and the score values range from 0 to 500 (maximum severity). An IBS-SSS questionnaire was filled-in by each randomized patient at both visits. We compared the difference between the overall score before and after the intervention.
次要结局
- Change in hydrogen excretion measured by lactulose breath test(15 days)
研究者
Juan Lasa
Clinical Professor
Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno