Skip to main content
OpenTrials
Completed

NCT Number: NCT03840538

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sjogren's Syndrome Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Dry Eye Syndromes Eye Diseases Immune System Diseases Joint Diseases Lacrimal Apparatus Diseases Mouth Diseases Musculoskeletal Diseases Rheumatic Diseases Salivary Gland Diseases Skin and Connective Tissue Diseases Stomatognathic Diseases Xerostomia

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Cairo University

Cairo, 9112, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • primary or scondary Sjogren's syndrome

Exclusion criteria

  • allergy to milk derivatives previous intake of antifungals

Treatment and study plan

Probiotic Product - Cap

Drug

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

Primary outcomes

  1. Pain assessment

    Time frame: 5 WEEKS

    Numerical Rating Scale ( NRS)

Secondary outcomes

  1. Candidal load

    Time frame: 5 weeks

    colony forming unit CFU/ml

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Feb 15, 2019
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.