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

NCT ID: NCT02317133

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2017-07-12

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?

Conditions

Henoch Schönlein Purpura

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

HSP: acute episode

Patients in this group are going through an acute episode of Henoch Schönlein Purpura.

Intervention: Blood samples Intervention: Stool samples

Blood samples

Intervention Type: BIOLOGICAL

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

Stool samples

Intervention Type: BIOLOGICAL

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

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

Blood samples

Intervention Type: BIOLOGICAL

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

Stool samples

Intervention Type: BIOLOGICAL

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

Control group

Control patients recruited from elective surgery candidates at the participating hospitals.

Intervention: Blood samples Intervention: Stool samples

Blood samples

Intervention Type: BIOLOGICAL

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

Stool samples

Intervention Type: BIOLOGICAL

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

Interventions

Blood samples

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

Intervention Type: BIOLOGICAL

Stool samples

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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)

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tu Anh Tran, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

CHRU de Montpellier - Hôpital Lapeyronie

Montpellier, , France

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 33734346 (View on PubMed)

Other Identifiers

2013-A01264-41

Identifier Type: OTHER

Identifier Source: secondary_id

AOIt/2013/TAT-01

Identifier Type: -

Identifier Source: org_study_id