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 @ 5:50 PM
Ignite Modification Date:
2025-12-24 @ 5:50 PM
NCT ID:
NCT06659068
Eligibility Criteria:
Inclusion Criteria:
* Patients who meet the SLICC criteria
* Patients with mild to moderate SLE (mild if SLEDAI-2K score \< 6 and moderate if SLEDAI-2K score: 6-12)
* Aged 18-55 years
* Willing to stop consuming vitamin D or multivitamin supplements containing vitamin D for at least 3 weeks before participating in the study
* Willing to stop consuming probiotics that were previously taken for at least 1 week before participating in the study
* If using prednisone, the dose must be stable (corticosteroid equivalent ≤ 20 mg/day) for at least 4 weeks before the study
* Willing to sign informed consent
Exclusion Criteria:
* Patients with severe SLE
* Patients with SLE with hypercalcemia (\> 2.60 mmol/l)
* Patients with SLE with liver dysfunction: serum Aspartate Transferase (AST) - and Alanine Transferase (ALT) levels \> 2 times the normal value or total serum bilirubin \> 1.5 times the normal value
* Patients undergoing hemodialysis or patients with serum creatinine \> 2.5 mg/dL
* Pregnant patients
* Patients with SLE with immunocompromised conditions such as HIV
* Patients with SLE with chronic infections such as pulmonary tuberculosis
* Patients currently undergoing antibiotic therapy
Drop out criteria:
* Patients who have been off medication for more than 3 weeks
* Patients who have passed away
* Patients who consume yogurt or supplements containing probiotics/synbiotics more than once consecutively in 1 week
* Patients who experience a change in immunosuppressive agents during the study
* Patients who are hospitalized due to a worsening condition during the intervention period
* Loss to follow-up
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT06659068
Study Brief:
Protocol Section:
NCT06659068