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NCT Number: NCT06659068

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Systemic Lupus Erythematosus (SLE) Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mohammad Hoesin General Hospital

Palembang, South Sumatera, 30126, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Seluang fish oil (Rasbora argyrotaenia) and synbiotic

Dietary Supplement

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

Placebo

Dietary Supplement

Patients received placebo capsules

Primary outcomes

  1. CD4+CD25+Foxp3+ regulatory T cells,

    Time frame: 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

  2. IL-17/IL-10 ratio

    Time frame: 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

  3. SLEDAI-2K score

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Universitas Sriwijaya

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Oct 26, 2024
Registry last updated
Oct 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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