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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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 Summary:

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?


Sponsor: Centre Hospitalier Universitaire de Nīmes

Current 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 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Numerical abnormalities in other blood cell lines [ Time Frame: Day 0 ]
  • Serum cytokine levels [ Time Frame: Day 0 ]
    ng/ml
  • Serum IgA levels [ Time Frame: Day 0 ]
    mg/l
  • Presence/absence of bacterial translocation [ Time Frame: Day 0 ]
  • Quantification of bacterial translocation [ Time Frame: Day 0 ]
    (10^8 copies / µl)
  • 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 ]
    Bacteroidetes, Firmicutes and Actinobacteria


Original Secondary Outcome: Same as current

Information By: Centre Hospitalier Universitaire de Nīmes

Dates:
Date Received: December 11, 2014
Date Started: February 2015
Date Completion: February 2017
Last Updated: October 24, 2016
Last Verified: October 2016