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.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Collecting questionnaires and biological samples.
- Who it may be relevant to
- Registry conditions: Juvenile Idiopathic Arthritis (JIA), Crohn Disease (CD), Ulcerative Colitis (UC). Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other 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
Primary outcome measures
- 3-days food diary, kidmed and medi-lite scores [Time frame: After two weeks]
Secondary outcome measures (1)
- Percentage of families with microbiota alteration [Time frame: After 6 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Italy · 4 centers
- AOU Meyer IRCCS — Florence
- Università La Sapienza di Roma — Roma
- Università di Foggia — Foggia
- Ospedale Villa Sofia Cervello, Università di Palermo — Palermo
Identifiers
NCT: NCT06862843 · DIETA-MICIREUMA