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NCT06862843Recruiting

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.

Source: ClinicalTrials.gov · Last updated 6 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
90 (estimated)
First submitted
25 Feb 2025
Start date
7 Feb 2024
Primary completion date
15 May 2025
Lead sponsor
Meyer Children's Hospital IRCCS
NCT number
NCT06862843

What you commit to

  • Study type: Observational
  • Planned participants: 90
  • From 7 Feb 2024 to the primary completion date, 15 May 2025
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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.

Other

  • For subjects affected by IBD:

Who the study is looking for

  • 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.

Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
AOU Meyer IRCCS
Coordinator of this site? Confirm its status
FlorenceItalyRecruiting
Università di Foggia
Coordinator of this site? Confirm its status
FoggiaItalyRecruiting
Ospedale Villa Sofia Cervello, Università di Palermo
Coordinator of this site? Confirm its status
PalermoItalyRecruiting
Università La Sapienza di Roma
Coordinator of this site? Confirm its status
RomaItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.