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

Universitas Sriwijaya

Status: Active, not recruiting

Conditions: Systemic Lupus Erythematosus (SLE)

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Seluang fish oil (Rasbora argyrotaenia) and synbiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT06659068

4.3/D.XVIII.6.8/ETIK/208/2023

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

Seluang fish oil (Rasbora argyrotaenia) and Synbiotic

Experimental group

Description:

Seluang fish oil (Rasbora argyrotaenia) and Synbiotic The patients were given a capsule containing seluang fish oil (Rasbora argyrotaenia) once a day and also synbiotic once a day

Treatment:

Dietary Supplement: Seluang fish oil (Rasbora argyrotaenia) and synbiotic

Placebo

Placebo Comparator group

Description:

Placebo The patients were given placebo capsules of seluang fish oil (Rasbora argyrotaenia) and synbiotics once a day

Treatment:

Dietary Supplement: Placebo