Probiotics in Systemic Lupus Erythematosus

Study Overview
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Brief Summary
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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
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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 Blood and urine samples for laboratory investigations will be withdrawn at baseline and at the end of the study.

Official Title
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Evaluation of the Clinical Outcome of Probiotics in Systemic Lupus Erythematosus

Conditions
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Systemic Lupus Erythematosus

Intervention / Treatment
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* Drug: Lacteol forte capsules


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Interventional, Prospective, randomized, controlled, open-label study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>20 patients will receive the standard therapy for 12 weeks | |
| Experimental: Interventional group<br>20 patients will receive the standard therapy in addition to two capsules once daily of probiotic Lacteol Forte® Capsules for 12 weeks | Drug: Lacteol forte capsules<br>* 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<br>* Other names: lactobacillus delbruekii and lactobacillus fermentum;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | At baseline and at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of immunologic parameters | Anti-dsDNA levels | At baseline and at 12 weeks | 
| Improvement of serum complement | Complements 3 and 4 | At baseline and at 12 weeks | 
| patients' quality of life | Assessment of patients' quality of life using the validated Arabic Lupus Patient-reported outcome survey version 1.8 (LupusPROv1.8) | At baseline and at 12 weeks | 
| Pain assessment | Pain assessment using the validated Arabic version of the Short-Form McGill Pain Questionnaire | At baseline and at 12 weeks | 
| Incidence of potential adverse effects | Monitoring for side and/or adverse effects | Weekly up to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotics, Lactobacillus, Systemic lupus erythematosus, SLEDAI-2K