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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case group | Families with at least a member affected with JIA or IBD (UC or CD) |
| |
| Control group | Families with all healty components |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collecting questionnaires and biological samples | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 3-days food diary, kidmed and medi-lite scores | After two weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of families with microbiota alteration | After 6 months |
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Inclusion Criteria:
For families with at least one child/adult affected by IBD/JIA:
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:
For subjects affected by JIA:
- No exclusion criteria
For healthy subjects:
- Any chronic inflammatory bowel disease, autoimmune disease, or ongoing infectious diseases.
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Cases: Families consisting of father, mother, and children aged between 0 and 18 years, in good health, with at least one member (child or adult) affected by IBD (Crohn's disease or ulcerative colitis), and families with a child affected by JIA.
Controls: Healthy families consisting of father, mother, and children aged between 0 and 18 years, in good health, and not affected by chronic inflammatory bowel diseases or any chronic autoimmune inflammatory diseases.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paolo Lionetti, MD, PhD, Ordinary Professor | Contact | +39 3398416059 | paolo.lionetti@unifi.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOU Meyer IRCCS | Recruiting | Florence | Italy | Italy |
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Blood samples Fecal samples
|
| Università La Sapienza di Roma | Recruiting | Roma | Roma | 00185 | Italy |
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| Università di Foggia | Recruiting | Foggia | Italy |
|
| Ospedale Villa Sofia Cervello, Università di Palermo | Recruiting | Palermo | Italy |
|
| ID | Term |
|---|---|
| D001171 | Arthritis, Juvenile |
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| D005247 | Feeding Behavior |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
| D001522 | Behavior, Animal |
| D001519 | Behavior |
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