Probiotics as a Prophylaxis to Prevent Clinical Manifestations of Oral Candidosis in Patients With Sjogren's Syndrome
1 other identifier
interventional
32
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jan 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedFirst Submitted
Initial submission to the registry
February 12, 2019
CompletedFirst Posted
Study publicly available on registry
February 15, 2019
CompletedFebruary 15, 2019
February 1, 2019
11 months
February 12, 2019
February 13, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Pain assessment
Numerical Rating Scale ( NRS)
5 WEEKS
Secondary Outcomes (1)
Candidal load
5 weeks
Study Arms (2)
Probiotic group
EXPERIMENTALProbiotic complex capsule taken twice daily for 5weeks
Placebo group
PLACEBO COMPARATORPlacebo capsule taken twice daily for 5 weeks
Interventions
probiotic capsule complex composed of L.acidophilus, L. bulgaricus, Streptococcus thermophilus, and Bifidobacterium bifidus
Eligibility Criteria
You may qualify if:
- primary or scondary Sjogren's syndrome
You may not qualify if:
- allergy to milk derivatives previous intake of antifungals
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Cairo University
Cairo, 9112, Egypt
Related Publications (1)
Kamal Y, Kandil M, Eissa M, Yousef R, Elsaadany B. Probiotics as a prophylaxis to prevent oral candidiasis in patients with Sjogren's syndrome: a double-blinded, placebo-controlled, randomized trial. Rheumatol Int. 2020 Jun;40(6):873-879. doi: 10.1007/s00296-020-04558-9. Epub 2020 Mar 26.
PMID: 32219478DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant lecturer
Study Record Dates
First Submitted
February 12, 2019
First Posted
February 15, 2019
Study Start
January 1, 2018
Primary Completion
December 1, 2018
Study Completion
January 1, 2019
Last Updated
February 15, 2019
Record last verified: 2019-02