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RECRUITING
NCT06775457
NA

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

Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

View on ClinicalTrials.gov

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.

Official title: Genome Analysis of Human Endogenous Retroviruses (HERVs) and Gut Microbiota in Patients With SARS-CoV-2 Infection, Kawasaki Disease and Other Febrile and Inflammatory Diseases With Systemic Involvement in Pediatric Age.

Key Details

Gender

All

Age Range

Any - 18 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2021-06-10

Completion Date

2025-12-31

Last Updated

2025-01-15

Healthy Volunteers

No

Interventions

OTHER

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.

Locations (5)

Ospedale Ramazzini di Carpi, Azienda USL di Modena UO Pediatria

Carpi, Modena, Italy

IRCCS Azienda Ospedaliero - Universitaria di Bologna, U.O. Pediatria d'Urgenza, Pronto Soccorso e Osservazione Breve ed Intensiva

Bologna, Italy

Azienda Ospedaliera-Universitaria di Modena

Modena, Italy

IRCCS Ospedale Pediatrico Bambino Gesù UOC Pediatria Generale

Roma, Italy

Ospedale Regina Margherita, Torino, UO Reumatologia Pediatrica

Torino, Italy