NCT06862843 Study on Eating Habits and Association with "omic" Profiles in Families with a Subject Affected by a Chronic Immune-mediated Inflammatory Pathology. Observational Multicenter Study.
| NCT ID | NCT06862843 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Meyer Children's Hospital IRCCS |
| Condition | Juvenile Idiopathic Arthritis (JIA) |
| Study Type | OBSERVATIONAL |
| Enrollment | 90 participants |
| Start Date | 2024-02-07 |
| Primary Completion | 2025-05-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 90 participants in total. It began in 2024-02-07 with a primary completion date of 2025-05-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The proposed study is part of a PNRR 2022 project (call "Non-Communicable Chronic Diseases (NCDs) with high impact on healthcare and social assistance systems," currently awaiting funding response) and represents the continuation of an observational clinical study named TRANSMIC, approved by the pediatric ethics committee of the Tuscany region. TRANSMIC was an integral part of a European research project within the joint programming initiative (JPI), under the HDHL-INTIMIC theme: "A Healthy Diet for a Healthy Life," aimed at understanding the cause-effect relationships between diet, gut microbiome, and human health. Understanding the role of diet in inflammatory bowel diseases (IBD) and exploring its role in autoimmune inflammatory conditions with joint manifestations, such as JIA, provides additional insights into the development, progression, and management of these conditions, opening new horizons for the use of dietary treatments in preventing these inflammatory conditions.
Eligibility Criteria
Inclusion Criteria: For families with at least one child/adult affected by IBD/JIA: * Father and mother with children aged between 0-18 years, in good health. * At least one adult or one child affected by IBD, or a child affected by JIA, regardless of ongoing therapy and without distinction of disease severity or activity. For healthy families: \- Father and mother with children aged between 0-18 years, in good health and not affected by chronic inflammatory bowel diseases or chronic autoimmune inflammatory diseases in general. Exclusion Criteria: For subjects affected by IBD: * Monogenic disease * Children with an ileostomy or who have undergone a colectomy For subjects affected by JIA: \- No exclusion criteria For healthy subjects: \- Any chronic inflammatory bowel disease, autoimmune disease, or ongoing infectious diseases.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06862843 clinical trial?
This trial is open to participants of all sexes, studying Juvenile Idiopathic Arthritis (JIA). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06862843 currently recruiting?
Yes, NCT06862843 is actively recruiting participants. Contact the research team at paolo.lionetti@unifi.it for enrollment information.
Where is the NCT06862843 trial being conducted?
This trial is being conducted at Florence, Italy, Roma, Italy, Foggia, Italy, Palermo, Italy.
Who is sponsoring the NCT06862843 clinical trial?
NCT06862843 is sponsored by Meyer Children's Hospital IRCCS. The trial plans to enroll 90 participants.