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 statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorMeyer Children's Hospital IRCCS

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Monogenic disease

Children with an ileostomy or who have undergone a colectomy

Trial population

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.

Trial design

Design model

Case-control

Time perspective

Retrospective

Treatments tested in this trial

  • Collecting questionnaires and biological samples

    Other intervention

    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

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Case group1 intervention
Group B: Control group1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
After two weeks

Secondary outcomes

1

Percentage of families with microbiota alteration

Time frame
After 6 months

Other outcomes

Sponsors and contacts

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