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

Completed

• Conditions: Henoch Schönlein Purpura
• Interventions: Biological: Blood samples; Biological: Stool samples

• Registration Number: NCT02317133
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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?

Study Timeline

• Study First Submitted: 2014-12-11
• Study First Submitted QC: 2014-12-12
• Study First Posted: 2014-12-15
• Study Start: 2015-02
• Primary Completion: 2017-07-11
• Study Completion: 2019-01-31
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-18
• Last Update Posted: 2019-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HSP: acute episode	Stool samples	Patients in this group are going through an acute episode of Henoch Schönlein Purpura. Intervention: Blood samples Intervention: Stool samples
HSP: remission	Stool samples	Patients in this group have had Henoch Schönlein Purpura in the past but currently have no symptoms. Intervention: Blood samples Intervention: Stool samples
HSP: acute episode	Blood samples	Patients in this group are going through an acute episode of Henoch Schönlein Purpura. Intervention: Blood samples Intervention: Stool samples
HSP: remission	Blood samples	Patients in this group have had Henoch Schönlein Purpura in the past but currently have no symptoms. Intervention: Blood samples Intervention: Stool samples
Control group	Blood samples	Control patients recruited from elective surgery candidates at the participating hospitals. Intervention: Blood samples Intervention: Stool samples
Control group	Stool samples	Control patients recruited from elective surgery candidates at the participating hospitals. Intervention: Blood samples Intervention: Stool samples

Primary Outcome Measures

Name	Time	Method
Percentage of blood Tregs	Day 0
Absolute Treg count	Day 0	number / mm\^3
Presence / absence of functional abnormality of plasma Tregs	Day 0

Secondary Outcome Measures

Name	Time	Method
Serum IgA levels	Day 0	mg/l
Serum cytokine levels	Day 0	ng/ml
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	(10\^8 copies / µl)
Presence/absence of bacterial translocation	Day 0
Distribution of bacteria taxa present in the intestine among 3 categories	Day 0	Bacteroidetes, Firmicutes and Actinobacteria

Trial Locations

Locations (2)

CHRU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, France

CHRU de Montpellier - Hôpital Lapeyronie; 🇫🇷 Montpellier, France