Probiotics in Systemic Lupus Erythematosus

• Status: Recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams University

Criteria

Inclusion Criteria:

1. Age 18-65 years, male or female.

2. Patients are willing to sign a written informed consent.

3. Patients fulfilling American college of rheumatology classification criteria for SLE.

4. Patients diagnosed with active systemic lupus erythematosus defined as SLEDAI-2K score more than 4.

Exclusion Criteria:

1. Patients ˂ 18 years or ˃65 years of age.

2. Patients with a history of drug allergies to probiotics administration.

3. Pregnant or breastfeeding females.

4. Current probiotics use.

5. Patients scheduled for surgical intervention during the study period or up to 2 weeks after the end of the study.

6. patients suffering from active severe neuropsychiatric manifestations of SLE.

7. Patients with other auto-immune diseases.

8. Patients suffering from any type of cancer.

9. patients participating in other clinical trials.