Study of the Role of Regulator T Cells in the Pathophysiology of Childhood Henoch Schönlein Purpura
Overview
- Phase
- Not Applicable
- Intervention
- Blood samples
- Conditions
- Henoch Schönlein Purpura
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Percentage of blood Tregs
- Status
- Completed
- Last Updated
- 5 months ago
Overview
Brief Summary
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.
Detailed Description
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?
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •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
Arms & Interventions
HSP: acute episode
Patients in this group are going through an acute episode of Henoch Schönlein Purpura. Intervention: Blood samples Intervention: Stool samples
Intervention: Blood samples
HSP: acute episode
Patients in this group are going through an acute episode of Henoch Schönlein Purpura. Intervention: Blood samples Intervention: Stool samples
Intervention: Stool samples
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
Intervention: Blood samples
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
Intervention: Stool samples
Control group
Control patients recruited from elective surgery candidates at the participating hospitals. Intervention: Blood samples Intervention: Stool samples
Intervention: Blood samples
Control group
Control patients recruited from elective surgery candidates at the participating hospitals. Intervention: Blood samples Intervention: Stool samples
Intervention: Stool samples
Outcomes
Primary Outcomes
Percentage of blood Tregs
Time Frame: Day 0
Absolute Treg count
Time Frame: Day 0
number / mm\^3
Presence / absence of functional abnormality of plasma Tregs
Time Frame: Day 0
Secondary Outcomes
- 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)