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

NCT ID: NCT03840538

Last Updated: 2019-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2019-01-01

Brief Summary

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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

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Conditions

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Sjogren's Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Probiotic group

Probiotic complex capsule taken twice daily for 5weeks

Group Type EXPERIMENTAL

Probiotic Product - Cap

Intervention Type DRUG

probiotic capsule complex composed of L.acidophilus, L. bulgaricus, Streptococcus thermophilus, and Bifidobacterium bifidus

Placebo group

Placebo capsule taken twice daily for 5 weeks

Group Type PLACEBO_COMPARATOR

Probiotic Product - Cap

Intervention Type DRUG

probiotic capsule complex composed of L.acidophilus, L. bulgaricus, Streptococcus thermophilus, and Bifidobacterium bifidus

Interventions

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Probiotic Product - Cap

probiotic capsule complex composed of L.acidophilus, L. bulgaricus, Streptococcus thermophilus, and Bifidobacterium bifidus

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* primary or scondary Sjogren's syndrome

Exclusion Criteria

* allergy to milk derivatives previous intake of antifungals
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Yasmine Kamal Ramadan

Assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cairo University

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type DERIVED
PMID: 32219478 (View on PubMed)

Other Identifiers

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20112012

Identifier Type: -

Identifier Source: org_study_id

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