Analyzing the role of human endogenous retroviruses in pediatric diseases
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.
This study is trying to see how certain viruses in our genes might affect kids with diseases like Kawasaki Disease and COVID-19, by looking at their immune responses and other factors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 5 sites (Carpi, Modena and 4 other locations) |
| Trial ID | NCT06775457 on ClinicalTrials.gov |
What this trial studies
This study investigates the relationship between human endogenous retroviruses (HERVs) and various pediatric diseases, including Kawasaki Disease and SARS-CoV-2 infection. It aims to evaluate how HERV expression may influence immune responses and clinical manifestations in affected children. The research involves collecting samples from pediatric patients diagnosed with these conditions to explore the potential link between genetic factors, environmental influences, and immune system regulation. The study also considers the role of gut microbiota in modulating immune responses related to these diseases.
Who should consider this trial
Good fit: Ideal candidates for this study are pediatric patients newly diagnosed with Kawasaki disease, vasculitis, SARS-CoV-2 infection, or febrile virosis.
Not a fit: Patients with chronic conditions unrelated to the specified diseases or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could enhance our understanding of the immune mechanisms involved in pediatric diseases and lead to improved treatment strategies.
How similar studies have performed: While the role of HERVs in disease is being explored, this specific approach focusing on pediatric conditions and gut microbiota interactions is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * None
Where this trial is running
Carpi, Modena and 4 other locations
- Ospedale Ramazzini di Carpi, Azienda USL di Modena UO Pediatria — Carpi, Modena, Italy (Recruiting)
- IRCCS Azienda Ospedaliero - Universitaria di Bologna, U.O. Pediatria d'Urgenza, Pronto Soccorso e Osservazione Breve ed Intensiva — Bologna, Italy (Recruiting)
- Azienda Ospedaliera-Universitaria di Modena — Modena, Italy (Recruiting)
- IRCCS Ospedale Pediatrico Bambino Gesù UOC Pediatria Generale — Roma, Italy (Recruiting)
- Ospedale Regina Margherita, Torino, UO Reumatologia Pediatrica — Torino, Italy (Recruiting)
Study contacts
- Principal investigator: Marianna Fabi, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Marianna Fabi, MD
- Email: marianna.fabi@aosp.bo.it
- Phone: 0512143012
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.