Probiotics as a Prophylaxis to Prevent Clinical Manifestations of Oral Candidosis in Patients With Sjogren's Syndrome
Phase 1
Completed
- Conditions
- Sjogren's Syndrome
- Interventions
- Drug: Probiotic Product - Cap
- Registration Number
- NCT03840538
- Lead Sponsor
- Cairo University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
Inclusion Criteria
- primary or scondary Sjogren's syndrome
Exclusion Criteria
- allergy to milk derivatives previous intake of antifungals
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Probiotic group Probiotic Product - Cap Probiotic complex capsule taken twice daily for 5weeks Placebo group Probiotic Product - Cap Placebo capsule taken twice daily for 5 weeks
- Primary Outcome Measures
Name Time Method Pain assessment 5 WEEKS Numerical Rating Scale ( NRS)
- Secondary Outcome Measures
Name Time Method Candidal load 5 weeks colony forming unit CFU/ml
Trial Locations
- Locations (1)
Cairo University
🇪🇬Cairo, Egypt