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临床试验/NCT03840538
NCT03840538已完成1 期

Probiotics as a Prophylaxis to Prevent Clinical Manifestations of Oral Candidosis in Patients With Sjogren's Syndrome

Cairo University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2018年1月1日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Probiotic complex capsule taken twice daily for 5weeks

干预措施: Probiotic Product - Cap (Drug)

Placebo group

Placebo Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yasmine Kamal Ramadan

Assistant lecturer

Cairo University

研究点 (1)

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