Clinical Trials in Italy / NCT06862843
Recruiting Observational

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.

NCT06862843 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2024-02-07
Last updated
2025-03-06

Condition(s) studied

Juvenile Idiopathic Arthritis (JIA)Crohn Disease (CD)Ulcerative Colitis (UC)

Investigational drug(s) / intervention(s)

Collecting questionnaires and biological samples

Collecting questionnaires and biological samples: For each family member will be collected a 3-days food diary, a food frequencies questionnaire and a questionnaire assessing the adherence to the mediterranean diet. Additionally, a blood sample for trascriptomic analysis and a fecal sample for gut microbiota analysis will be collected

Study 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

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

Trial sites (4)

FacilityCityRegionStatus
AOU Meyer IRCCS Florence Italy Recruiting
Università La Sapienza di Roma Roma Roma Recruiting
Università di Foggia Foggia Italy Recruiting
Ospedale Villa Sofia Cervello, Università di Palermo Palermo Italy Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06862843 on ClinicalTrials.gov ↗ ← All trials in Italy