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.
Recruiting · NCT06862843 · Observational (researchers observe without assigning treatment) · Lead sponsor: Meyer Children's Hospital IRCCS
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
8 locations listed.
- Università di Foggia - Foggia, Italy
- Università di Foggia - Foggia, Italy
- Ospedale Villa Sofia Cervello, Università di Palermo - Palermo, Italy
- Ospedale Villa Sofia Cervello, Università di Palermo - Palermo, Italy
- AOU Meyer IRCCS - Florence, Italy, Italy
- AOU Meyer IRCCS - Florence, Italy, Italy
- Università La Sapienza di Roma - Roma, Roma, Italy
- Università La Sapienza di Roma - Roma, Roma, Italy