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

NCT02317133 | Completed

• 2 other identifiers: AOIt/2013/TAT-012013-A01264-41
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Henoch Schönlein Purpura

Keywords

Tregs; bacterial translocation; cytokines

Outcome Measures

Primary Outcomes (3)

• Percentage of blood Tregs

  Day 0

• Absolute Treg count

  number / mm\^3

  Day 0

• Presence / absence of functional abnormality of plasma Tregs

  Day 0

Secondary Outcomes (7)

• Numerical abnormalities in other blood cell lines

  Day 0

• Serum cytokine levels

  Day 0

• Serum IgA levels

  Day 0

• Presence/absence of bacterial translocation

  Day 0

• Quantification of bacterial translocation

  Day 0

Study Arms (3)

HSP: acute episode

Patients in this group are going through an acute episode of Henoch Schönlein Purpura. Intervention: Blood samples Intervention: Stool samples

Biological: Blood samples; Biological: 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

Biological: Blood samples; Biological: Stool samples

Control group

Control patients recruited from elective surgery candidates at the participating hospitals. Intervention: Blood samples Intervention: Stool samples

Biological: Blood samples; Biological: Stool samples

Interventions

Blood samples BIOLOGICAL

Compared to routine practice, 3 additional tubes of blood will be drawn for the observational needs of this study.

Control group; HSP: acute episode; HSP: remission

Stool samples BIOLOGICAL

Stool samples will be collected for the observational needs of this study (and are not part of routine practice).

Control group; HSP: acute episode; HSP: remission

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Three different populations will be included in this study: (A) patients presenting with an acute episode of Henoch Schönlein purpura; (B) patients who have had an episode of Henoch Schönlein purpura in the past, but currently present with no symptoms; (C) a group of control patients recruted from elective surgery candidates at the participating hospitals.

You may qualify if:

• 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
• 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
• 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
• Subjects free from infectious, inflammatory or autoimmune diseases
• Candidates for elective surgery (circumcision, urological surgery, removal of tonsils and adenoids)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (2)

CHRU de Montpellier - Hôpital Lapeyronie

Montpellier, 34295, France

Location

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

Related Publications (1)

• Filleron A, Tran TA, Hubert A, Letierce A, Churlaud G, Kone-Paut I, Saadoun D, Cezar R, Corbeau P, Rosenzwajg M. Regulatory T cell/Th17 balance in the pathogenesis of paediatric Behcet disease. Rheumatology (Oxford). 2021 Dec 24;61(1):422-429. doi: 10.1093/rheumatology/keab253.

  PMID: 33734346 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Stool samples: DNA extractions for microbiota analysis. Blood samples: DNA extractions for bacterial translocation analysis Blood samples: samples remaining will be kept for further analysis

MeSH Terms

Conditions

IgA Vasculitis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Vasculitis; Vascular Diseases; Cardiovascular Diseases; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemostatic Disorders; Hemorrhagic Disorders; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Immune Complex Diseases; Hypersensitivity; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Tu Anh Tran, MD, PhD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2014
• First Posted: December 15, 2014
• Study Start: February 1, 2015
• Primary Completion: July 12, 2017
• Study Completion: July 12, 2017
• Last Updated: November 19, 2025

Record last verified: 2019-03

Locations

FR (2)