Genome Analysis of Human Endogenous Retroviruses (HERVs)(COVID19)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
sample collection
Other interventionBlood 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.
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: PatientsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
HERVs analysis
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.
Time frame
through study completion, an average of 1 year2
Microbiota characterization
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).
Time frame
through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov