Systemic Lupus Erythematosus (SLE)
Conditions
Keywords
Seluang fish oil, Rasbora argyrotaenia, Systemic Lupus Erythematosus, SLE, IL-17/IL-10 ratio, CD4+, CD25+, Foxp3+, T-regulator, Disease Activity
Brief 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.
Interventions
DIETARY_SUPPLEMENTSeluang fish oil (Rasbora argyrotaenia) and synbiotic
The patients received 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
DIETARY_SUPPLEMENTPlacebo
Patients received placebo capsules
Sponsors
Universitas Sriwijaya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Triple (Participant, Care Provider, Investigator)
Intervention model description
The study was designed as a single-center double-blind randomized controlled clinical trial. Participants were randomized into two groups receiving seluang fish oil and synbiotics supplementation, or placebo.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CD4+CD25+Foxp3+ regulatory T cells, | From enrollment to the end of the treatment at 12 weeks | To determine the effectiveness of adding seluang fish oil extract capsules with synbiotics compared to placebo in CD4+CD25+Foxp3+ regulatory T cells concentration change |
| IL-17/IL-10 ratio | From enrollment to the end of the treatment at 12 weeks | To determine the effectiveness of adding seluang fish oil extract capsules with synbiotics compared to placebo in IL-17/IL-10 ratio changes |
| SLEDAI-2K score | From enrollment to the end of the treatment at 12 weeks | To determine the effectiveness of adding seluang fish oil extract capsules with synbiotics compared to placebo towards SLEDAI-2K score changes |
Countries
Indonesia
Outcome results
None listed