Association Between Helicobacter Pylori Infection and Disease Activity in Patients With Systemic Lupus Erythematosus (SLE)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 115
- 主要终点
- Association between H. pylori infection status and SLE disease activity
研究概览
简要总结
A cross-sectional, observational study aims to evaluate the relationship between Helicobacter pylori infection and disease activity in patients diagnosed with systemic lupus erythematosus (SLE), using a combination of structured patient interviews, standardized disease assessments, and laboratory detection of H. pylori by stool antigen testing .
详细描述
the study explores the potential role of chronic H. pylori infection as a trigger or aggravating factor in SLE, an autoimmune disorder characterized by overactive immune responses that cause multisystem organ damage . The rationale is based on recent findings suggesting that chronic infections may worsen autoimmune disease activity by persistent immune stimulation and production of cross-reactive autoantibodies . SLE patients attending clinics at Assiut University Hospital will be assessed over one year; inclusion requires confirmed SLE diagnosis per established criteria, absence of recent antibiotics/PPIs, and consent. Clinical data, disease activity (via SLEDAI-2K), and socio-demographic information will be collected through detailed medical interviews and laboratory investigations, particularly focusing on stool-based antigen tests for H. pylori. All data will be securely recorded for statistical analysis assessing the bidirectional impact of infection status and SLE severity .
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult patients (aged ≥18 years) with a confirmed diagnosis of SLE according to the American College of Rheumatology (ACR) or Systemic Lupus International Collaborating Clinics (SLICC) classification criteria.
- •Patients who provide written informed consent to participate in the study. Patients who have not received antibiotics or proton pump inhibitors (PPIs) in the four weeks
排除标准
- •Patients with a history of gastric surgery or known gastrointestinal malignancy.
- •Patients currently receiving immunosuppressive therapy for conditions other than SLE.
- •Patients with coexisting autoimmune diseases other than SLE.
- •Pregnant or lactating women.
- •Patients with active infections (other than H. pylori) at the time of enrollment.
结局指标
主要结局
Association between H. pylori infection status and SLE disease activity
时间窗: baseline
The study will determine whether the presence or absence of H. pylori infection (measured by stool antigen test) is linked to higher disease activity in SLE, as quantified by the SLEDAI-2K score
次要结局
未报告次要终点
研究者
Wanees Ebrahim
resident at the Internal Medicine department
Assiut University