Actively Recruiting

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

Genome Analysis of Human Endogenous Retroviruses (HERVs) and Gut Microbiota in Children With SARS-CoV-2 Infection, Kawasaki Disease, and Other Febrile and Inflammatory Diseases

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

120

Participants Needed

5

Research Sites

N/A

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 gut microbiota in children with various inflammatory diseases such as Kawasaki Disease, IgA Vasculitis/Schonlein-Henoch's Purpura, SARS-CoV-2 infection, and febrile virosis. The study aims to understand how HERVs and gut bacteria might influence immune responses and disease symptoms in pediatric patients. This research could provide new insights for managing and treating these conditions. The study involves collecting blood and fecal samples from children diagnosed with the listed diseases. Blood samples are analyzed to study HERVs, while fecal samples are used to characterize the gut microbiota. Patients are enrolled consecutively as they receive a diagnosis, and the study monitors changes over approximately one year to assess associations between HERVs, gut bacteria, and clinical outcomes. Participants will have evaluations including sample collection for laboratory analyses. Researchers will measure HERV activity and gut microbiota profiles to explore their links with disease manifestations. The primary outcomes focus on these analyses throughout the study period, enabling a better understanding of immune regulation in these pediatric inflammatory diseases. The study is expected to last about one year for each participant.

CONDITIONS

Brief 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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - Through study completion, an average of 1 year

Participants provide blood and fecal samples during evaluation visits for analysis of Human Endogenous Retroviruses (HERVs) and characterization of gut microbiota.

Evaluation visits as scheduled

Long-term Monitoring

Duration - Through study completion, an average of 1 year

Participants are monitored over time to observe the progression and characteristics of their disease and immune response.

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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