Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-24 @ 6:35 PM
NCT ID:
NCT05433857
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05433857
Study Brief:
Protocol Section:
NCT05433857