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

Cairo University (CU)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Sjogren's Syndrome

Treatments: Drug: Probiotic Product - Cap

Study type: Interventional

Funder types: Other

Identifiers

NCT03840538

20112012

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• primary or scondary Sjogren's syndrome

Exclusion criteria

• allergy to milk derivatives previous intake of antifungals

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 2 patient groups, including a placebo group

Probiotic group

Experimental group

Description:

Probiotic complex capsule taken twice daily for 5weeks

Treatment:

Drug: Probiotic Product - Cap

Placebo group

Placebo Comparator group

Description:

Placebo capsule taken twice daily for 5 weeks

Treatment:

Drug: Probiotic Product - Cap