Effect of Anti-inflammatory Diet in Systemic Lupus Erythematous
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- PROMIS pain interference
研究概览
简要总结
To study the effect of anti-inflammatory diet on clinical and biological outcomes in lupus
详细描述
The investigators aim to evaluate how inflammation changes in individuals with lupus and to identify molecules and gut bacteria that may help predict disease flares. Blood and stool samples will be analyzed in the laboratory and compared with samples collected from the same participants following dietary changes.
This is an exploratory study designed to generate preliminary data on the short-term effects of dietary changes and treatment on blood biomarkers and the gut microbiome. The findings may provide insights into the mechanisms underlying lupus and could ultimately contribute to the development of new therapeutic approaches.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •patients who meet the 2019 EULAR/ACR Classification Criteria for SLE
- •patients who are on Cellcept or Myfortic for at least 3 months prior to screening
- •patients with a score of ≥55 on the Patient Reported Outcomes Measurement Information System (PROMIS) Pain interference scale.
排除标准
- •pregnant or lactating patients,
- •patients with food allergy
- •patients on antibiotics within 4 weeks of the screening
- •patients that change the SLE therapy during the length of the study (12 weeks).
结局指标
主要结局
PROMIS pain interference
时间窗: 6 weeks
PROMIS Pain Interference: Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference. Scores are typically reported as T-scores ranging from approximately 20 to 80 (theoretical range varies by item bank). Higher scores indicate worse outcomes, reflecting greater pain interference with daily activities.
PROMIS fatigue
时间窗: 6 weeks
PROMIS Fatigue: Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue. Scores are typically reported as T-scores ranging from approximately 20 to 80. Higher scores indicate worse outcomes, reflecting greater fatigue.
次要结局
- PROMIS physical function(6 weeks)
研究者
Monica Guma
Professor
University of California, San Diego