Actively Recruiting

Phase Not Applicable
Age: 0 - 18Years
All Genders
ID06775457

Genome Analysis of Human Endogenous Retroviruses and Gut Microbiota in Children with SARS-CoV-2 Infection, Kawasaki Disease, and Other Pediatric Inflammatory Diseases

Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-01-15

120

Participants Needed

5

Research Sites

237 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the role of Human Endogenous Retroviruses (HERVs), ancient DNA sequences, and the gut microbiota, the community of microorganisms in the digestive tract, in children with various diseases. These include Kawasaki Disease, IgA Vasculitis/Schonlein-Henoch's Purpura, SARS-CoV-2 infection, and febrile virosis. The study aims to understand if there is a link between HERV expression, gut bacteria types, and clinical symptoms in these pediatric conditions, potentially offering new insights for care and treatment. The study involves collecting blood and fecal samples from pediatric patients diagnosed with the diseases mentioned. Blood samples will be analyzed to study HERVs, while fecal samples will be used to characterize the gut microbiota. This approach will help examine how HERV activity and gut bacteria profiles may relate to disease onset, severity, and immune response in affected children. Participants will be monitored throughout the study, with assessments focusing on HERVs and gut microbiota over about one year. The main outcomes measured include the analysis of HERVs and the characterization of microbiota throughout the study period. The results may help identify markers for disease severity and guide personalized treatments and follow-up care in pediatric patients with these inflammatory and infectious conditions.

CONDITIONS

Official Title

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

Who Can Participate

Age: 0 - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 5 locations

1

Ospedale Ramazzini di Carpi, Azienda USL di Modena UO Pediatria

Carpi, Modena, Italy, 41012

Actively Recruiting

2

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

Bologna, Italy, 40138

Actively Recruiting

3

Azienda Ospedaliera-Universitaria di Modena

Modena, Italy, 41100

Actively Recruiting

4

IRCCS Ospedale Pediatrico Bambino Gesù UOC Pediatria Generale

Roma, Italy, 00165

Actively Recruiting

5

Ospedale Regina Margherita, Torino, UO Reumatologia Pediatrica

Torino, Italy, 10126

Actively Recruiting

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Research Team

M

Marianna Fabi, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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