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ID06862843

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

All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Sample Collection

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)

Long-term Monitoring

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

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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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