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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 90
- Locations
- 4
- Primary Endpoint
- 3-days food diary, kidmed and medi-lite scores
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Retrospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
3-days food diary, kidmed and medi-lite scores
Time Frame: After two weeks
Secondary Outcomes
- Percentage of families with microbiota alteration(After 6 months)
Investigators
Paolo Lionetti
Principal Investigator
Meyer Children's Hospital IRCCS