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

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT03840538

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sjogren's Syndrome	Drug: Probiotic Product - Cap	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jan 1, 2018

Actual Primary Completion Date :

Dec 1, 2018

Actual Study Completion Date :

Jan 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Probiotic group Probiotic complex capsule taken twice daily for 5weeks	Drug: Probiotic Product - Cap probiotic capsule complex composed of L.acidophilus, L. bulgaricus, Streptococcus thermophilus, and Bifidobacterium bifidus
Placebo Comparator: Placebo group Placebo capsule taken twice daily for 5 weeks	Drug: Probiotic Product - Cap probiotic capsule complex composed of L.acidophilus, L. bulgaricus, Streptococcus thermophilus, and Bifidobacterium bifidus

Arm

Intervention/Treatment

Experimental: Probiotic group

Probiotic complex capsule taken twice daily for 5weeks

Drug: Probiotic Product - Cap

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

Placebo Comparator: Placebo group

Placebo capsule taken twice daily for 5 weeks

Drug: Probiotic Product - Cap

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

Outcome Measures

Primary Outcome Measures

Pain assessment [5 WEEKS]
Numerical Rating Scale ( NRS)

Secondary Outcome Measures

Candidal load [5 weeks]
colony forming unit CFU/ml

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

primary or scondary Sjogren's syndrome

Exclusion Criteria:

allergy to milk derivatives previous intake of antifungals

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairo University	Cairo		Egypt	9112

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yasmine Kamal Ramadan, Assistant lecturer, Cairo University

ClinicalTrials.gov Identifier:

NCT03840538

Other Study ID Numbers:

20112012

First Posted:

Feb 15, 2019

Last Update Posted:

Feb 15, 2019

Last Verified:

Feb 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Sjogren's Syndrome

Syndrome

Study Results

No Results Posted as of Feb 15, 2019