Henoch Schönlein Purpura Clinical Trial
— FOX-TREGOfficial title:
Study of the Role of Regulator T Cells in the Pathophysiology of Childhood Henoch Schönlein Purpura
Verified date | March 2019 |
Source | Centre Hospitalier Universitaire de Nimes |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | January 31, 2019 |
Est. primary completion date | July 11, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 17 Years |
Eligibility |
General inclusion criteria for all sub-populations included in the study - The child (with age- and comprehension-skill-appropriate information) and parents (or persons exercising parental authority) have been informed about the implementation of the study, its objectives, constraints and patient rights - The child (depending on age) and parents (or persons exercising parental authority) have given their free and informed consent and signed the consent - The patient must be insured or beneficiary of a health insurance plan Inclusion criteria for population A: Henoch Schönlein purpura, acute episodes - The diagnosis of Henoch Schönlein purpura was made by a physician according to the EULAR / PRES / PRINTO 2010 criteria (purpura predominantly on the lower limbs associated with one of the following criteria: abdominal pain, arthralgia or arthritis, kidney damage or suggestive histology (immune deposits dominated by Immunoglobulin A (IgA)) - The patient is not treated via immunosuppression (steroids or other immunosuppressive / biotherapy) and has not been treated like this for at least 15 days Inclusion criteria for population B: Henoch Schönlein purpura in remission - The diagnosis of Henoch Schönlein purpura was made by a physician according to the EULAR / PRES / PRINTO 2010 criteria - The patient has has a Henoch Schönlein purpura episode in the past, and no longer has any symptoms of the disease - The patient is not treated via immunosuppression (steroids or other immunosuppressive / biotherapy) and has not been treated like this for at least 15 days Inclusion criteria for population C: controls - Subjects free from infectious, inflammatory or autoimmune diseases - Candidates for elective surgery (circumcision, urological surgery, removal of tonsils and adenoids) 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 |
Country | Name | City | State |
---|---|---|---|
France | CHRU de Montpellier - Hôpital Lapeyronie | Montpellier | |
France | CHRU de Nîmes - Hôpital Universitaire Carémeau | Nîmes Cedex 09 |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Nimes |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of blood Tregs | Day 0 | ||
Primary | Absolute Treg count | number / mm^3 | Day 0 | |
Primary | Presence / absence of functional abnormality of plasma Tregs | Day 0 | ||
Secondary | Numerical abnormalities in other blood cell lines | Day 0 | ||
Secondary | Serum cytokine levels | ng/ml | Day 0 | |
Secondary | Serum IgA levels | mg/l | Day 0 | |
Secondary | Presence/absence of bacterial translocation | Day 0 | ||
Secondary | Quantification of bacterial translocation | (10^8 copies / µl) | Day 0 | |
Secondary | Number of bacterial species detected in the intestinal microbiota | Day 0 | ||
Secondary | Distribution of bacteria taxa present in the intestine among 3 categories | Bacteroidetes, Firmicutes and Actinobacteria | Day 0 |