Efficacy of Synbiotic Supplementation on IL-10, TGF-B and Disease Activity in Systemic Lupus Erythematosus Patients; A Randomized, Double-Blind, Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- IL-10
研究概览
简要总结
Dysregulation of normal flora leads to dysbiosis, which has recently been investigated as an important internal environmental factor and has been proven to be associated with both active and remission phases of SLE, and can be used to predict disease activity. Administration of synbiotics is expected to restore mucosal barrier function and create an anti-inflammatory environment in the gut, by suppressing pro-inflammatory factors and increasing anti-inflammatory factors (IL-10 and TGF-β), leading to improved disease activity in SLE patients.
详细描述
This research is a double blind randomized controlled trial study. The study subjects were 36 patients diagnosed with mild to moderate lupus activity, randomly divided into 2 groups, who received synbiotic supplementation once daily for 12 weeks and the group that received placebo. Serum IL-10 and TGF-β levels and the degree of disease activity using MEX-SLEDAI score were measured before and after treatment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients diagnosed with mild to moderate Systemic Lupus Erythematosus (SLE).
- •Patients aged over 18 years.
- •Willing to participate in the study by signing an informed consent form.
- •Have not consumed yogurt or supplements containing probiotics, prebiotics, or synbiotics within the last 2 weeks.
排除标准
- •Severe SLE. 2, Pregnant or breastfeeding.
- •History of allergy to probiotics or prebiotics.
- •Patients with other immune-related disorders, whether autoimmune or immunocompromised conditions such as HIV or rheumatoid arthritis.
- •SLE with pulmonary tuberculosis.
- •Currently undergoing antibiotic therapy.
- •SLE with malignancy.
- •Drop-Out Criteria
- •Patients discontinue synbiotic intake for more than 2 weeks.
- •Occurrence of serious adverse drug reactions requiring discontinuation of the study drug.
- •Patients consume yogurt or supplements containing probiotics/synbiotics more than once per week outside of the study intervention, or undergo changes in steroid-sparing agents during the study period.
- •Patients require hospitalization due to symptom exacerbation during the intervention period.
- •Loss to follow-up.
研究组 & 干预措施
Placebo
The patients were given placebo capsules once a day
干预措施: Placebo (Dietary Supplement)
Synbiotic
The patients were given a capsule containing synbiotic once a day
干预措施: Synbiotic (Dietary Supplement)
结局指标
主要结局
IL-10
时间窗: From enrollment to the end of the treatment at 12 weeks
To determine the effectiveness of adding synbiotics compared to placebo on IL-10 concentration change in Systemic Lupus Erythematosus Patients
MEX-SLEDAI score
时间窗: From enrollment to the end of the treatment at 12 weeks
To determine the effectiveness of adding synbiotics compared to placebo towards MEX-SLEDAI score changes
TGF-B
时间窗: From enrollment to the end of the treatment at 12 weeks
To determine the effectiveness of adding synbiotics compared to placebo on TGF-B concentration change in Systemic Lupus Erythematosus Patients
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