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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | 20 patients will receive the standard therapy for 12 weeks | |
| Interventional group | Experimental | 20 patients will receive the standard therapy in addition to two capsules once daily of probiotic Lacteol Forte® Capsules for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lacteol forte capsules | Drug | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rana Sayed, PhD | Faculty of Pharmacy, Ain Shams University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University Hospitals | Cairo | Abbasseya | Egypt |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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Interventional, Prospective, randomized, controlled, open-label study.
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|
| 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 |