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

Primary Purpose

Sjogren's Syndrome

Status

Completed

Phase

Phase 1

Locations

Egypt

Study Type

Interventional

Intervention

Probiotic Product - Cap

About this trial

This is an interventional prevention trial for Sjogren's Syndrome

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

primary or scondary Sjogren's syndrome

Exclusion Criteria:

allergy to milk derivatives previous intake of antifungals

Sites / Locations

Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Probiotic group

Placebo group

Arm Description

Probiotic complex capsule taken twice daily for 5weeks

Placebo capsule taken twice daily for 5 weeks

Outcomes

Primary Outcome Measures

Pain assessment

Numerical Rating Scale ( NRS)

Secondary Outcome Measures

Candidal load

colony forming unit CFU/ml

Full Information

NCT ID

NCT03840538

First Posted

February 12, 2019

Last Updated

February 13, 2019

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT03840538

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

January 1, 2018 (Actual)

Primary Completion Date

December 1, 2018 (Actual)

Study Completion Date

January 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

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

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sjogren's Syndrome

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Probiotic group

Arm Type

Experimental

Arm Description

Probiotic complex capsule taken twice daily for 5weeks

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

Placebo capsule taken twice daily for 5 weeks

Intervention Type

Drug

Intervention Name(s)

Probiotic Product - Cap

Intervention Description

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

Primary Outcome Measure Information:

Title

Pain assessment

Description

Numerical Rating Scale ( NRS)

Time Frame

5 WEEKS

Secondary Outcome Measure Information:

Title

Candidal load

Description

colony forming unit CFU/ml

Time Frame

5 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: primary or scondary Sjogren's syndrome Exclusion Criteria: allergy to milk derivatives previous intake of antifungals

Facility Information:

Facility Name

Cairo University

City

Cairo

ZIP/Postal Code

9112

Country

Egypt

12. IPD Sharing Statement

Citations:

PubMed Identifier

32219478

Citation

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.

Results Reference

derived

Learn more about this trial

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

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