Impact of Additional Treatment With Saccharomyces Boulardii on Quality of Life in Patients With Mild Forms of Ulcerative Colitis and Crohn Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 主要终点
- Patients quality of life
研究概览
简要总结
The goal of the study is to assess the impact of treatment with dietary supplement containing Saccharomyces boulardii (used as an addition to standard therapy), on quality of life of patients with mild forms of ulcerative colitis and Crohn disease, as well as those in remission fulfilling criteria for irritable bowel syndrome.
Patients included will be randomly assigned in two groups and subsequently administered with formulation containing Saccharomyces boulardii or placebo for 4 weeks. Patient's quality of life will be assessed by questionnaire at the enrolment and 4 weeks after initiating the therapy.
详细描述
Saccharomyces boulardii has been reported to have positive impact on intestinal epithelial barrier as well as immune system. It has been proven to be efficient in treatment and prophylaxis of travellers diarrhoea, HIV associated diarrhoea, antibiotics associated diarrhoea and Clostridium difficile infection. However there is a limited data available on effect of therapy with Saccharomyces boulardii (as add-on to standard therapy) in patients with inflammatory bowel disease. Nevertheless, knowing the effect Saccharomyces boulardii has on intestinal flora, intestinal epithelium and immune system it can be hypothesised that Saccharomyces boulardii used as add-on to standard therapy in IBD patients can lead to improvement in symptoms and therefore in quality of life.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histological diagnosis of ulcerative colitis or Crohn disease
- •colonoscopy in last six months confirming mild disease form according to endoscopic criteria (Mayo score, simple endoscopic score)
- •colonoscopy in last six months confirming endoscopic remission with fulfilled clinical Rome IV criteria for irritable bowl syndrome
- •patients with mild disease form are eligible only if treated with mesalazine only
- •patients in remission eligible for inclusion if treated with mesalazine, biologics, azathioprine or methotrexate
- •signed informed consents
排除标准
- •no colonoscopy in last six months
- •moderate to severe disease according to colonosopy findings (Mayo score, simple endoscopic score)
- •indeterminate colitis
研究组 & 干预措施
Boulardii
Patients will be administered with formulation containing 500 mg of Saccharomyces boulardii and 10 mg of Vitamin D3 once daily, as an addition to their standard therapy.
干预措施: Boulardii (Dietary Supplement)
Placebo
Patients will be administered with placebo as an addition to their standard therapy.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Patients quality of life
时间窗: 8 weeks
Quality of life measured will be measured by questionnaire at day 1, 4 weeks after enrolment and 8 weeks after enrolment. Questionnaire comprises 10 questions considering presence of symptoms of inflammatory bowel disease as well as their effect on well-being. Each question can be answered with one of seven answers contributing 1 to 7 points to final score. Final score ranges between 10 and 70 with higher values corresponding with higher quality of life.
次要结局
- Disease clinical activity(8 weeks)
研究者
Nikola Panic
MD, PhD
University Clinic Dr Dragisa Misovic-Dedinje