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Recruiting Not applicable

Genome Analysis of Human Endogenous Retroviruses (HERVs)(COVID19)

NCT06775457 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2021-06-10
Last updated
2025-01-15

Condition(s) studied

SARS CoV-2Kawasaki DiseaseRetrovirus Infection

Investigational drug(s) / intervention(s)

sample collection

sample collection: Blood samples and fecal samples will be taken from patients during evaluation visits. Blood samples will be analyzed for the study of HERVs. While fecal samples will be analyzed for the characterization of gut microbiota.

Study summary

Human Endogenous Retroviruses (HERVs) are ancient sequences that became integrated into our DNA during evolutionary processes.

The significance of their presence in DNA is still being studied, but HERVs appear to be involved in the regulation of the immune response.

The gut microbiota is the set of microorganisms that physiologically colonize the gastrointestinal tract. Progressively increasing attention is being paid to the gut microbiota and its potential role in diseases of various kinds. In particular, it has recently been shown how abnormalities in the microbiota can affect immune regulation by determining the occurrence of certain diseases. One objective of the study is to evaluate whether there is an association between the expression of HERVs and clinical manifestations in pediatric age in patients with various diseases such as Kawasaki Disease, IgA Vasculitis/Schonlein-Henoch's Purpura, SARS-CoV-2 infection, or, finally, febrile virosis.

Another objective of the study is to evaluate whether there is an association between the presence of particular types of bacteria in the gut microbiota and clinical manifestations in pediatric age in patients with Kawasaki Disease, IgA Vasculitis/Schonlein-Henoch purpura, SARS-CoV-2 infection or febrile virosis.

The results from this may open new perspectives for both the care and therapeutic management of children with these diseases.

Eligibility

Sex
ALL
Min age
—
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria: * Pediatric patients, newly diagnosed with Kawasaki disease * Pediatric patients, newly diagnosed with Vasculitis * Pediatric patients, newly diagnosed with SARS-CoV-2 infection * Pediatric patients, newly diagnosed with febrile virosis * Pediatric patients with inflammatory diseases with systemic involvement Exclusion Criteria: * None

Primary outcome measure(s)

  • HERVs analysis — through study completion, an average of 1 year
    Investigate the expression levels of specific HERVs families in PBMCs of patients with Kawasaki disease, IgA vasculitis/Schonlein-Henoch purpura, SARS- CoV-2 infection, and febrile virosis and inflammatory diseases with systemic involvement in pediatric age.
  • Microbiota characterization — through study completion, an average of 1 year
    Characterize the MI composition of subjects with Kawasaki disease, IgA vasculitis/Schonlein-Henoch's purpura, SARS-CoV-2 infection, and febrile virosis and inflammatory diseases with systemic involvement in pediatric age included by culture-independent method (16S rRNA gene sequencing).

Trial sites (5)

FacilityCityRegionStatus
Ospedale Ramazzini di Carpi, Azienda USL di Modena UO Pediatria Carpi Modena Recruiting
IRCCS Azienda Ospedaliero - Universitaria di Bologna, U.O. Pediatria d'Urgenza, Pronto Soccorso e Osservazione Breve ed Intensiva Bologna Italy Recruiting
Azienda Ospedaliera-Universitaria di Modena Modena Italy Recruiting
IRCCS Ospedale Pediatrico Bambino Gesù UOC Pediatria Generale Roma Italy Recruiting
Ospedale Regina Margherita, Torino, UO Reumatologia Pediatrica Torino Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06775457 on ClinicalTrials.gov ↗ ← All trials in Italy