Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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
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
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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