Study of the Role of Regulator T Cells in the Pathophysiology of Childhood Henoch Schönlein Purpura
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Percentage of blood Tregs
研究概览
简要总结
The primary objective of this study is to search for evidence of quantitative or functional defects in plasma regulatory T cells (Tregs) in pediatric patients with Henoch Schönlein Purpura (HSP) as compared to a control population.
详细描述
The secondary questions/objectives for this study are:
A. During an inflammatory HSP flare, is there a quantitative and / or qualitative defect in plasma Tregs? Are such blood anomalies real or are they due to a modification of the distribution of theses cells to localized sites? B. In the asymptomatic phase, are there quantitative or functional abnormalities among Tregs in subjects with HSP compared to healthy control subjects? C. Are Treg abnormalities associated with modifications in other blood cell lineages, including B cells secreting IgA and abnormally glycosylated IgA1, and secretion of cytokines during acute relapses and during the asymptomatic phase? D. Can streptococcus or other oral or digestive pathogens (bacterial or viral) (as suggested in other chronic diseases such as rheumatoid arthritis ) provoke (via stimulation Th3) isotype commutation towards secretion of IgA1 at the origin of HSP? Does HSP intestinal damage or imbalance of the intestinal microbiota allow the translocation of intestinal microorganisms that sustain this stimulation?
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •The patient is participating in another interventional study or is in an exclusion period determined by a previous study
- •The child refuses to participate in the study
- •Parents (or persons with parental responsibility if any) refuse to sign the consent
- •It is impossible to correctly inform the patient or his/her parents (or persons with parental authority if any)
- •The patient has another inflammatory or autoimmune disease
- •Patient on immunosuppressive / biotherapy treatments
研究组 & 干预措施
HSP: acute episode
Patients in this group are going through an acute episode of Henoch Schönlein Purpura.
Intervention: Blood samples Intervention: Stool samples
干预措施: Blood samples (Biological)
HSP: acute episode
Patients in this group are going through an acute episode of Henoch Schönlein Purpura.
Intervention: Blood samples Intervention: Stool samples
干预措施: Stool samples (Biological)
HSP: remission
Patients in this group have had Henoch Schönlein Purpura in the past but currently have no symptoms.
Intervention: Blood samples Intervention: Stool samples
干预措施: Blood samples (Biological)
HSP: remission
Patients in this group have had Henoch Schönlein Purpura in the past but currently have no symptoms.
Intervention: Blood samples Intervention: Stool samples
干预措施: Stool samples (Biological)
Control group
Control patients recruited from elective surgery candidates at the participating hospitals.
Intervention: Blood samples Intervention: Stool samples
干预措施: Blood samples (Biological)
Control group
Control patients recruited from elective surgery candidates at the participating hospitals.
Intervention: Blood samples Intervention: Stool samples
干预措施: Stool samples (Biological)
结局指标
主要结局
Percentage of blood Tregs
时间窗: Day 0
Absolute Treg count
时间窗: Day 0
number / mm\^3
Presence / absence of functional abnormality of plasma Tregs
时间窗: Day 0
次要结局
- Serum IgA levels(Day 0)
- Serum cytokine levels(Day 0)
- Number of bacterial species detected in the intestinal microbiota(Day 0)
- Numerical abnormalities in other blood cell lines(Day 0)
- Quantification of bacterial translocation(Day 0)
- Presence/absence of bacterial translocation(Day 0)
- Distribution of bacteria taxa present in the intestine among 3 categories(Day 0)