efficacy of seluang fish oil (rasbora argyrotaenia) and synbiotics supplementation on cd4+cd25+ foxp3+ t-regulator cells, il17/il-10 ratio, and disease activity in systemic lupus erythematosus patients

Conditions: Systemic Lupus Erythematosus (SLE)

Summary: the study aimed to evaluate the efficacy of seluang fish oil (rasbora argyrotaenia) and synbiotics (containing lactobacillus helveticus r0052 60%, bifidobacterium infantis r0033 20%, bifidobacterium bifidum r0071 20% and frukto-oligosaccharide 80 mg) supplementation compared to placebo towards systemic lupus erythematosus disease activity index (sledai)-2k score, il-17/il-10 ratio and cd4+ cd25+ foxp3+t-regulator levels in systemic lupus erythematosus (sle) patients. the current study was designed as a single-center double-blind randomized controlled clinical trial. the participants were voluntarily recruited 18-55 years old sle patients diagnosed based on slicc criteria, with mild to moderate disease activity, were clinically stable for ≥ 4 months (on prednison ≤ 20 mg/day or equivalent) and willingly ceased vitamin d and probiotic consumption during the trial study. participants were randomized into two groups receiving seluang fish oil and synbiotics supplementation, or placebo. evaluations were conducted on week 4, 8 and 12 for clinical symptoms, side effects and adherence. il-17/il-10 ratio and cd4+ cd25+ foxp3+t-regulator levels were evaluated at the beginning and at the end of the 12 week trial for analysis.


Eligibility criteria:
inclusion criteria: * patients who meet the slicc criteria * patients with mild to moderate sle (mild if sledai-2k score \&lt; 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 (\&gt; 2.60 mmol/l) * patients with sle with liver dysfunction: serum aspartate transferase (ast) - and alanine transferase (alt) levels \&gt; 2 times the normal value or total serum bilirubin \&gt; 1.5 times the normal value * patients undergoing hemodialysis or patients with serum creatinine \&gt; 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

Keywords: seluang fish oil rasbora argyrotaenia systemic lupus erythematosus sle il-17/il-10 ratio cd4+ cd25+ foxp3+ t-regulator disease activity