A Proof-of-concept Double-blind Randomized Placebo-controlled Trial of Probiotics in Systemic Sclerosis Associated Gastrointestinal Disease
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- mean difference between probiotics group versus placebo group in gastrointestinal change score from baseline to day 60 of treatment.
研究概览
简要总结
SSc-associated gastrointestinal (GI) involvement is common, with no effective treatment. Probiotics may have beneficial effects on symptoms as supported by one small open-label study (n=10) that demonstrated decreased bloating symptoms in SSc patients after 2 months of probiotics. This study aims to determine (i) whether 60 days of Vivomixx probiotics result in greater GI symptom improvement than placebo in SSc outpatients, assessed using an interview-administered 34-item Gastrointestinal Tract (GIT) questionnaire and (ii) whether 60 days versus 120 days of probiotics result in greater GI symptom improvement in SSc outpatients, assessed using the GIT questionnaire.
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
- Triple (Participant, Care Provider, Investigator)
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
- •SSc that fulfills the American College of Rheumatology (ACR, 1990) classification criteria or the proposed European League Against Rheumatism (EULAR) criteria for very early diagnosis of systemic sclerosis.
- •SSc overlap syndromes (ie SSc occurring in overlap with other connective tissue diseases)
- •SSc-associated GI symptoms (heartburn, dysphagia, vomiting, bloating/distension, faecal soilage, diarrhoea, constipation) not due to other causes as determined by clinical evaluation, with a total GIT score of at least 0.10
- •Stable doses of immunosuppressive treatment, corticosteroids, and GI medications for 30 days.
排除标准
- •On anti-biotics or probiotics within the last 30 days
- •Current serious infections requiring hospitalization
- •Long-term indwelling catheter, including patients on total parenteral nutrition
- •Females who are lactating or pregnant
研究组 & 干预措施
Active vs Placebo
In phase I, subjects will be randomized into either the Vivomixx probiotics or placebo arm of the study at a 1:1 ratio. All randomized subjects will receive probiotics (4 sachets/ day or 1800 billion bacteria/day) or placebo (4 placebo sachets/day) for the first 60 days.
干预措施: Vivomixx probiotics (Dietary Supplement)
60 days of Active vs 120 days of Active
In phase II, subjects from both arms in phase I will receive Vivomixx probiotics 4 sachets/ day for another 60 days. Comparison will be made between the arm receiving 60 days of Vivomixx probiotics vs 120 days of Vivomixx probiotics
干预措施: Vivomixx probiotics (Dietary Supplement)
结局指标
主要结局
mean difference between probiotics group versus placebo group in gastrointestinal change score from baseline to day 60 of treatment.
时间窗: After 60 days of either placebo treatment or active drug treatment
次要结局
- mean difference between 60 days of probiotics versus 120 days of probiotics in gastrointestinal change score from baseline to day 120 of treatment.(After 120 days of placebo treatment or active drug treatment)