Probiotics as a Prophylaxis to Prevent Clinical Manifestations of Oral Candidosis in Patients With Sjogren's Syndrome
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Pain assessment
研究概览
简要总结
Sjogren's syndrome is an autoimmune chronic disease. It has two forms Primary Sjogren's syndrome charactrized by dry eyes and dry mouth. Secondary Sjogren's syndrome characterized by rheumatoid diseases as rheumatoid arthritis, scleroderma and lupus erythematosus. SS patients are most liable to oral candidiasis , so they need prophylaxis aganist oral candidiasis. Probiotic bacteria are live microorganisms that when administered in adequate amounts confer benefits to health.Probiotics are commonly used as a prophylaxis aganist oral candidosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary or scondary Sjogren's syndrome
排除标准
- •allergy to milk derivatives previous intake of antifungals
研究组 & 干预措施
Probiotic group
Probiotic complex capsule taken twice daily for 5weeks
干预措施: Probiotic Product - Cap (Drug)
Placebo group
Placebo capsule taken twice daily for 5 weeks
干预措施: Probiotic Product - Cap (Drug)
结局指标
主要结局
Pain assessment
时间窗: 5 WEEKS
Numerical Rating Scale ( NRS)
次要结局
- Candidal load(5 weeks)
研究者
Yasmine Kamal Ramadan
Assistant lecturer
Cairo University
