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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- CD4+CD25+Foxp3+ regulatory T cells,
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
CD4+CD25+Foxp3+ regulatory T cells,
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
未报告次要终点
研究者
Yuniza
Principal investigator, Division of Allergy Immunology Faculty Member, Department of Internal Medicine, Universitas Sriwijaya/Mohammad Hoesin General Hospital
Universitas Sriwijaya