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NCT03840538 Clinical Trial

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

Sjogren's Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03840538
Other study ID # 20112012
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date January 1, 2018
Est. completion date January 1, 2019

Study information
Verified date February 2019
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 32
Est. completion date January 1, 2019
Est. primary completion date December 1, 2018
Accepts healthy volunteers No
Gender All
Age group 30 Years to 70 Years
Eligibility Inclusion Criteria:

- primary or scondary Sjogren's syndrome

Exclusion Criteria:

- allergy to milk derivatives previous intake of antifungals

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Probiotic Product - Cap
probiotic capsule complex composed of L.acidophilus, L. bulgaricus, Streptococcus thermophilus, and Bifidobacterium bifidus

Locations
Country Name City State
Egypt Cairo University Cairo

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain assessment Numerical Rating Scale ( NRS) 5 WEEKS
Secondary Candidal load colony forming unit CFU/ml 5 weeks
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