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.

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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Key information

Conditions

Juvenile Idiopathic Arthritis (JIA) Arthritis Arthritis, Juvenile Autoimmune Diseases Behavior Behavior, Animal Colitis Colitis, Ulcerative Colonic Diseases Connective Tissue Diseases Crohn Disease Crohn Disease (CD) Digestive System Diseases Feeding Behavior Gastroenteritis Gastrointestinal Diseases Immune System Diseases Inflammatory Bowel Diseases Intestinal Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases Ulcerative Colitis (UC)

Sex eligibility

All sexes

Study type

Observational

Primary location

AOU Meyer IRCCS, Florence, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

3-days food diary, kidmed and medi-lite scores

Time frame: After two weeks

Secondary outcomes

Percentage of families with microbiota alteration

Time frame: After 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Paolo Lionetti, MD, PhD, Ordinary Professor

CONTACT

[email protected]

+39 3398416059

Sponsors and collaborators

Lead sponsor

Meyer Children's Hospital IRCCS

Other

Registry information

Acronym: DIETA-MICIREUM

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Mar 6, 2025
Registry last updated: Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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