Henoch Schönlein PurpuraFOX-TREGNCT02317133
Study of the Role of Regulator T Cells in the Pathophysiology of Childhood Henoch Schönlein Purpura
An observational study of Henoch Schönlein Purpura, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Henoch Schönlein Purpura
- What is being tested?
- Blood samples and Stool samples
- How many people
- 100 participants
- Where
- 2 sitesFrance
- Study dates
- Feb 2015to 12 Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Subjects free from infectious, inflammatory or autoimmune diseases
- Candidates for elective surgery (circumcision, urological surgery, removal of tonsils and adenoids)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHRU de Montpellier - Hôpital Lapeyronie
Montpellier, 34295
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029
About this study
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.
Read the detailed description
The secondary questions/objectives for this study are:
- 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
- Being tested
- Blood samples, Stool samples
- Keywords
- Tregs, bacterial translocation, cytokines
- Medical subject headings
- IgA Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesBiological
Compared to routine practice, 3 additional tubes of blood will be drawn for the observational needs of this study.
Stool samplesBiological
Stool samples will be collected for the observational needs of this study (and are not part of routine practice).
| Study group | Role | What they receive |
|---|---|---|
| HSP: acute episode | Patients in this group are going through an acute episode of Henoch Schönlein Purpura.
Intervention: Blood samples Intervention: Stool samples Receives: 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 Receives: 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 Receives: Biological: Blood samples; Biological: Stool samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of blood Tregs
Measured: Day 0
Absolute Treg count
number / mm^3
Measured: Day 0
Presence / absence of functional abnormality of plasma Tregs
Measured: Day 0
Secondary outcomes (7)
Numerical abnormalities in other blood cell lines
Measured: Day 0
Serum cytokine levels
ng/ml
Measured: Day 0
Serum IgA levels
mg/l
Measured: Day 0
Presence/absence of bacterial translocation
Measured: Day 0
Quantification of bacterial translocation
(10^8 copies / µl)
Measured: Day 0
Number of bacterial species detected in the intestinal microbiota
Measured: Day 0
Distribution of bacteria taxa present in the intestine among 3 categories
Bacteroidetes, Firmicutes and Actinobacteria
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2014 (estimated)
- Study startFeb 2015
- Primary completion12 Jul 2017
- Study completion12 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Henoch Schönlein PurpuraStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tu Anh Tran, MD, PhD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02317133
- Sponsor's protocol ID
- AOIt/2013/TAT-01
- Other IDs
- 2013-A01264-41
- Acronym
- FOX-TREG
- Status last verified
- Mar 2019
- First submitted
- 11 Dec 2014
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33734346
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Role of Regulator T Cells in the Pathophysiology of Childhood Henoch Schönlein Purpura
- ClinicalTrials.gov ID
- NCT02317133
- Acronym / sponsor ID
- FOX-TREG / AOIt/2013/TAT-01
- Conditions
- Henoch Schönlein Purpura
- Keywords
- Tregs, bacterial translocation, cytokines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- 12 Jul 2017 (actual)
- Study completion
- 12 Jul 2017 (actual)
- First posted
- 15 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HSP: acute episode | – | Biological: Blood samples, Biological: Stool samplesPatients in this group are going through an acute episode of Henoch Schönlein Purpura. Intervention: Blood samples Intervention: Stool samples |
| HSP: remission | – | Biological: Blood samples, Biological: Stool samplesPatients in this group have had Henoch Schönlein Purpura in the past but currently have no symptoms. Intervention: Blood samples Intervention: Stool samples |
| Control group | – | Biological: Blood samples, Biological: Stool samplesControl patients recruited from elective surgery candidates at the participating hospitals. Intervention: Blood samples Intervention: Stool samples |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- Subjects free from infectious, inflammatory or autoimmune diseases
- Candidates for elective surgery (circumcision, urological surgery, removal of tonsils and adenoids)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplesCompared to routine practice, 3 additional tubes of blood will be drawn for the observational needs of this study. | Biological | Control group, HSP: acute episode, HSP: remission |
| Stool samplesStool samples will be collected for the observational needs of this study (and are not part of routine practice). | Biological | Control group, HSP: acute episode, HSP: remission |
Primary outcome
Percentage of blood Tregs
Time frame: Day 0
Absolute Treg count
Time frame: Day 0
number / mm^3
Presence / absence of functional abnormality of plasma Tregs
Time frame: Day 0
7 secondary outcomes
Numerical abnormalities in other blood cell lines
Time frame: Day 0
Serum cytokine levels
Time frame: Day 0
Serum IgA levels
Time frame: Day 0
Presence/absence of bacterial translocation
Time frame: Day 0
Quantification of bacterial translocation
Time frame: Day 0
Number of bacterial species detected in the intestinal microbiota
Time frame: Day 0
Distribution of bacteria taxa present in the intestine among 3 categories
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Results publication: PubMed 33734346Filleron 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tu Anh Tran, MD, PhD principal investigator
Centre Hospitalier Universitaire de Nīmes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Henoch Schönlein Purpura, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of blood Tregs (time frame: Day 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02317133, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.