Exploring the link between diet and immune-related diseases in families

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.

This study is trying to see how the diets of families with members who have conditions like Juvenile Idiopathic Arthritis, Crohn's Disease, or Ulcerative Colitis affect their health and treatment options.

Quick facts

• Study type: Observational
• Enrollment: 90 (estimated)
• Sex: All
• Sponsor: Meyer Children's Hospital IRCCS (other)
• Locations: 4 sites (Florence, Italy and 3 other locations)
• Trial ID: NCT06862843 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate the relationship between dietary habits and 'omic' profiles in families with at least one member affected by chronic immune-mediated inflammatory conditions, specifically Juvenile Idiopathic Arthritis (JIA), Crohn Disease (CD), and Ulcerative Colitis (UC). By collecting questionnaires and biological samples, the study seeks to understand how diet influences the development and management of these inflammatory diseases. It builds on previous research that highlighted the connection between diet, gut microbiome, and health outcomes, potentially paving the way for dietary interventions in treatment strategies.

Who should consider this trial

Good fit: Ideal candidates include families with children aged 0-18 years, where at least one child or adult is affected by IBD or JIA.

Not a fit: Patients with monogenic diseases, ileostomies, or colectomies, as well as those with chronic inflammatory bowel diseases or autoimmune diseases, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new dietary recommendations that help manage or prevent chronic inflammatory conditions in affected individuals.

How similar studies have performed: Previous studies have shown promising results in understanding the impact of diet on inflammatory conditions, suggesting that this approach is both relevant and potentially beneficial.

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.

Where this trial is running

Florence, Italy and 3 other locations

• AOU Meyer IRCCS — Florence, Italy, Italy (RECRUITING)
• Università La Sapienza di Roma — Roma, Roma, Italy (RECRUITING)
• Università di Foggia — Foggia, Italy (RECRUITING)
• Ospedale Villa Sofia Cervello, Università di Palermo — Palermo, Italy (RECRUITING)

Study contacts

• Study coordinator: Paolo Lionetti, MD, PhD, Ordinary Professor

Conditions: Juvenile Idiopathic Arthritis, Crohn Disease, Ulcerative Colitis, JIA, Dietary habits, CD, UC, IBD