Trials / Completed
CompletedNCT02317133
Study of the Role of Regulator T Cells in the Pathophysiology of Childhood Henoch Schönlein Purpura
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (actual)
- Sponsor
- Centre Hospitalier Universitaire de Nīmes · Academic / Other
- Sex
- All
- Age
- 3 Years – 17 Years
- Healthy volunteers
- Not accepted
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?
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Blood samples | Compared to routine practice, 3 additional tubes of blood will be drawn for the observational needs of this study. |
| BIOLOGICAL | Stool samples | Stool samples will be collected for the observational needs of this study (and are not part of routine practice). |
Timeline
- Start date
- 2015-02-01
- Primary completion
- 2017-07-12
- Completion
- 2017-07-12
- First posted
- 2014-12-15
- Last updated
- 2025-11-19
Locations
2 sites across 1 country: France
Source: ClinicalTrials.gov record NCT02317133. Inclusion in this directory is not an endorsement.