Status:
COMPLETED
Probiotics in Systemic Lupus Erythematosus
Lead Sponsor:
Ain Shams University
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 system...
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 contro...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05433857
Start Date
June 10 2022
End Date
February 28 2024
Last Update
November 19 2025
Active Locations (1)
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1
Ain Shams University Hospitals
Cairo, Abbasseya, Egypt