Efficacy of Synbiotic Supplementation on IL-10, TGF-B and Disease Activity in Systemic Lupus Erythematosus Patients

This research is a double blind randomized controlled trial study. The study subjects were 36 patients diagnosed with mild to moderate lupus activity, randomly divided into 2 groups, who received synbiotic supplementation once daily for 12 weeks and the group that received placebo. Serum IL-10 and TGF-β levels and the degree of disease activity using MEX-SLEDAI score were measured before and after treatment.

Inclusion criteria

• All patients diagnosed with mild to moderate Systemic Lupus Erythematosus (SLE).
• Patients aged over 18 years.
• Willing to participate in the study by signing an informed consent form.
• Have not consumed yogurt or supplements containing probiotics, prebiotics, or synbiotics within the last 2 weeks.

Exclusion criteria

• Severe SLE. 2, Pregnant or breastfeeding. 3. History of allergy to probiotics or prebiotics. 4. Patients with other immune-related disorders, whether autoimmune or immunocompromised conditions such as HIV or rheumatoid arthritis.

• SLE with pulmonary tuberculosis. 6. Currently undergoing antibiotic therapy. 7. SLE with malignancy.

Drop-Out Criteria

• Patients discontinue synbiotic intake for more than 2 weeks.
• Death.
• Occurrence of serious adverse drug reactions requiring discontinuation of the study drug.
• Patients consume yogurt or supplements containing probiotics/synbiotics more than once per week outside of the study intervention, or undergo changes in steroid-sparing agents during the study period.
• Patients require hospitalization due to symptom exacerbation during the intervention period.
• Loss to follow-up.