Actively Recruiting
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.
Led by Meyer Children's Hospital IRCCS · Updated on 2025-03-06
90
Participants Needed
4
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This observational multicenter study explores the relationship between eating habits and biological profiles in families with a member affected by chronic immune-mediated inflammatory diseases such as Juvenile Idiopathic Arthritis (JIA), Crohn Disease (CD), and Ulcerative Colitis (UC). It continues previous research aimed at understanding how diet influences inflammatory bowel diseases and autoimmune conditions with joint involvement, contributing to knowledge about disease development, progression, and potential dietary prevention strategies. Participants include families with at least one member affected by JIA or IBD, as well as healthy families. Each family member will provide dietary information using a 3-day food diary, food frequency questionnaire, and Mediterranean diet adherence questionnaire. Biological samples including blood for transcriptomic analysis and fecal samples for gut microbiota analysis will also be collected to study the association between diet and disease. Participants will be assessed shortly after enrollment using dietary scores from the food diaries and questionnaires. Researchers will monitor changes in gut microbiota over six months to evaluate microbiota alterations among families. The study involves collecting and analyzing dietary and biological data to better understand how diet and microbiota relate to chronic inflammatory diseases in families, with no treatment interventions involved.
CONDITIONS
Brief Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Families with children aged between 0 and 18 years
- Father and mother in good health
- At least one adult or child affected by Inflammatory Bowel Disease (IBD) or a child affected by Juvenile Idiopathic Arthritis (JIA) for case families
- For healthy families, no members affected by chronic inflammatory bowel diseases or chronic autoimmune inflammatory diseases
- All family members in good health
You will not qualify if you...
- For IBD subjects: presence of monogenic disease
- For IBD subjects: children with an ileostomy or who have undergone colectomy
- For healthy subjects: any chronic inflammatory bowel disease, autoimmune disease, or ongoing infectious diseases
- No exclusion criteria for JIA subjects
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 weeks
Participants provide questionnaires and biological samples including a 3-days food diary, food frequency questionnaire, adherence to the Mediterranean diet questionnaire, blood sample for transcriptomic analysis, and fecal sample for gut microbiota analysis.
1 visit (in-person)
Duration - 6 months
Participants' data including microbiota alterations are observed and analyzed over time.
No additional visits required
Trial Site Locations
Total: 4 locations
1
AOU Meyer IRCCS
Florence, Italy, Italy
Actively Recruiting
2
Università La Sapienza di Roma
Roma, Roma, Italy, 00185
Actively Recruiting
3
Università di Foggia
Foggia, Italy
Actively Recruiting
4
Ospedale Villa Sofia Cervello, Università di Palermo
Palermo, Italy
Actively Recruiting
Research Team
P
Paolo Lionetti, MD, PhD, Ordinary Professor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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