Probiotics in Systemic Lupus Erythematosus
Primary Purpose
Systemic Lupus Erythematosus
Status
Recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Lacteol forte capsules
Sponsored by
About this trial
This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring Probiotics, Lactobacillus, Systemic lupus erythematosus, SLEDAI-2K
Eligibility Criteria
Inclusion Criteria:
- Age 18-65 years, male or female.
- Patients are willing to sign a written informed consent.
- Patients fulfilling American college of rheumatology classification criteria for SLE.
- Patients diagnosed with active systemic lupus erythematosus defined as SLEDAI-2K score more than 4.
Exclusion Criteria:
- Patients ˂ 18 years or ˃65 years of age.
- Patients with a history of drug allergies to probiotics administration.
- Pregnant or breastfeeding females.
- Current probiotics use.
- Patients scheduled for surgical intervention during the study period or up to 2 weeks after the end of the study.
- patients suffering from active severe neuropsychiatric manifestations of SLE.
- Patients with other auto-immune diseases.
- Patients suffering from any type of cancer.
- patients participating in other clinical trials.
Sites / Locations
- Ain Shams University HospitalsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
Interventional group
Arm Description
20 patients will receive the standard therapy for 12 weeks
20 patients will receive the standard therapy in addition to two capsules once daily of probiotic Lacteol Forte® Capsules for 12 weeks
Outcomes
Primary Outcome Measures
Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
Change in disease activity measured by SLEDAI-2K score. The most appropriate SLEDAI-2K cut-off score for definition of active disease which links to the need to increase therapy is 3 or 4
Secondary Outcome Measures
Improvement of immunologic parameters
Anti-dsDNA levels
Improvement of serum complement
Complements 3 and 4
patients' quality of life
Assessment of patients' quality of life using the validated Arabic Lupus Patient-reported outcome survey version 1.8 (LupusPROv1.8)
Pain assessment
Pain assessment using the validated Arabic version of the Short-Form McGill Pain Questionnaire
Incidence of potential adverse effects
Monitoring for side and/or adverse effects
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05433857
Brief Title
Probiotics in Systemic Lupus Erythematosus
Official Title
Evaluation of the Clinical Outcome of Probiotics in Systemic Lupus Erythematosus
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 10, 2022 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Dysbiosis, or disruption of the gut microbiota, leads to the onset of autoimmunity. Increasing data suggest that the gut microbiota is changed in various murine lupus models as well as in human systemic lupus erythematosus SLE patients. Ingestion of lactobacilli, which have immunoregulatory properties, may be a viable strategy for controlling disease development and progression in patients with lupus, such as increasing the remission period and decreasing flare frequency.
Detailed Description
Patients will be recruited and evaluated for eligibility.
Patients who met the eligibility criteria will be randomly assigned to either control or interventional group.
Patients in the control group will receive their standard therapy for 12 weeks and patients in the interventional group will receive their standard therapy plus one sachet daily of lacteol forte sachets for 12 weeks.
Collection of demographic data, full medication history, and full medical history will be performed at baseline and every 4 weeks.
Assessment of disease activity using SLEDAI-2K score, quality of life using the validated Arabic LupusPROv1.8 questionnaire, and Pain assessment using the validated Arabic version of the Short-Form McGill Pain Questionnaire will be performed at baseline and at the end of the study.
Safety and tolerability monitoring will be performed weekly using a side effect and/or adverse effect monitoring sheet.
Blood and urine samples for laboratory investigations will be withdrawn at baseline and at the end of the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
Probiotics, Lactobacillus, Systemic lupus erythematosus, SLEDAI-2K
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Interventional, Prospective, randomized, controlled, open-label study.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
20 patients will receive the standard therapy for 12 weeks
Arm Title
Interventional group
Arm Type
Experimental
Arm Description
20 patients will receive the standard therapy in addition to two capsules once daily of probiotic Lacteol Forte® Capsules for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Lacteol forte capsules
Other Intervention Name(s)
lactobacillus delbruekii and lactobacillus fermentum
Intervention Description
probiotic Lacteol Forte® capsules (5 billion heat-killed Lactobacillus LB, corresponding to lactobacillus delbruekii and lactobacillus fermentum) Two capsules are To be taken once daily
Primary Outcome Measure Information:
Title
Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
Description
Change in disease activity measured by SLEDAI-2K score. The most appropriate SLEDAI-2K cut-off score for definition of active disease which links to the need to increase therapy is 3 or 4
Time Frame
At baseline and at 12 weeks
Secondary Outcome Measure Information:
Title
Improvement of immunologic parameters
Description
Anti-dsDNA levels
Time Frame
At baseline and at 12 weeks
Title
Improvement of serum complement
Description
Complements 3 and 4
Time Frame
At baseline and at 12 weeks
Title
patients' quality of life
Description
Assessment of patients' quality of life using the validated Arabic Lupus Patient-reported outcome survey version 1.8 (LupusPROv1.8)
Time Frame
At baseline and at 12 weeks
Title
Pain assessment
Description
Pain assessment using the validated Arabic version of the Short-Form McGill Pain Questionnaire
Time Frame
At baseline and at 12 weeks
Title
Incidence of potential adverse effects
Description
Monitoring for side and/or adverse effects
Time Frame
Weekly up to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18-65 years, male or female.
Patients are willing to sign a written informed consent.
Patients fulfilling American college of rheumatology classification criteria for SLE.
Patients diagnosed with active systemic lupus erythematosus defined as SLEDAI-2K score more than 4.
Exclusion Criteria:
Patients ˂ 18 years or ˃65 years of age.
Patients with a history of drug allergies to probiotics administration.
Pregnant or breastfeeding females.
Current probiotics use.
Patients scheduled for surgical intervention during the study period or up to 2 weeks after the end of the study.
patients suffering from active severe neuropsychiatric manifestations of SLE.
Patients with other auto-immune diseases.
Patients suffering from any type of cancer.
patients participating in other clinical trials.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hend Mahran, BSc
Phone
+201157884145
Email
hend.mohran@pharma.asu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rana Sayed, PhD
Organizational Affiliation
Faculty of Pharmacy, Ain Shams University
Official's Role
Study Director
Facility Information:
Facility Name
Ain Shams University Hospitals
City
Cairo
State/Province
Abbasseya
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dahlia A Hussein, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Probiotics in Systemic Lupus Erythematosus
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