Actively Recruiting
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
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
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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
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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