Probiotics in Systemic Lupus Erythematosus

Phase 2

Recruiting

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: 1. Patients will be recruited and evaluated for eligibility.

2. Patients who met the eligibility criteria will be randomly assigned to either control or interventional group.

3. 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.

4. Collection of demographic data, full medication history, and full medical history will be performed at baseline and every 4 weeks.

5. 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.

6. Safety and tolerability monitoring will be performed weekly using a side effect and/or adverse effect monitoring sheet.

7. Blood and urine samples for laboratory investigations will be withdrawn at baseline and at the end of the study.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Interventional group	Lacteol forte capsules	20 patients will receive the standard therapy in addition to two capsules once daily of probiotic Lacteol Forte® Capsules for 12 weeks

Primary Outcome Measures

Name	Time	Method
Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)	At baseline and at 12 weeks	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

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

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