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

Not Applicable

Active, not recruiting

• Conditions: Systemic Lupus Erythematosus (SLE)

• Registration Number: NCT06659068
• Lead Sponsor: Universitas Sriwijaya

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-16
• Study First Submitted: 2024-09-30
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-23
• Last Update Submitted: 2024-10-23
• Study First Posted: 2024-10-26
• Last Update Posted: 2024-10-26
• Primary Completion: 2024-12-31
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Mohammad Hoesin General Hospital; 🇮🇩 Palembang, South Sumatera, Indonesia