Study of the Role of Regulator T Cells in the Pathophysiology of Childhood Henoch Schönlein Purpura

Henoch Schönlein Purpura Clinical Trial

— FOX-TREG  

Official title:

Study of the Role of Regulator T Cells in the Pathophysiology of Childhood Henoch Schönlein Purpura

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02317133
• Other study ID #: AOIt/2013/TAT-01
• Secondary ID: 2013-A01264-41
• Status: Completed
• Start date: February 2015
• Est. completion date: January 31, 2019

Study information

• Verified date: March 2019
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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?

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Henoch Schönlein Purpura
• Purpura
• Purpura, Schoenlein-Henoch

Intervention

Biological:
• Blood samples
Compared to routine practice, 3 additional tubes of blood will be drawn for the observational needs of this study.
• Stool samples
Stool samples will be collected for the observational needs of this study (and are not part of routine practice).

Locations

Country	Name	City	State
France	CHRU de Montpellier - Hôpital Lapeyronie	Montpellier
France	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

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