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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.

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.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06862843
Acronym
DIETA-MICIREUM
Enrollment
90
Registered
2025-03-06
Start date
2024-02-07
Completion date
2025-11-15
Last updated
2025-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn Disease (CD), Juvenile Idiopathic Arthritis (JIA), Ulcerative Colitis (UC)

Keywords

JIA, Dietary habits, CD, UC, IBD

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.

Interventions

OTHERCollecting 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

Sponsors

Meyer Children's Hospital IRCCS
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
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

Design outcomes

Primary

MeasureTime frame
3-days food diary, kidmed and medi-lite scoresAfter two weeks

Secondary

MeasureTime frame
Percentage of families with microbiota alterationAfter 6 months

Countries

Italy

Contacts

Primary ContactPaolo Lionetti, MD, PhD, Ordinary Professor
paolo.lionetti@unifi.it+39 3398416059

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026