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. (DIETA-MICIREUM)

March 3, 2025 updated by: Paolo Lionetti, Meyer Children's Hospital IRCCS

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Florence, Italy
        • Recruiting
        • AOU Meyer IRCCS
        • Contact:
      • Foggia, Italy
      • Palermo, Italy
        • Recruiting
        • Ospedale Villa Sofia Cervello, Università di Palermo
        • Contact:
      • Roma, Italy, 00185

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Case group
Families with at least a member affected with JIA or IBD (UC or CD)
Other: Collecting 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
Control group
Families with all healty components
Other: Collecting 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
3-days food diary, kidmed and medi-lite scores
Time Frame: After two weeks
After two weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of families with microbiota alteration
Time Frame: After 6 months
After 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meyer Children's Hospital IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2024

Primary Completion (Estimated)

May 15, 2025

Study Completion (Estimated)

November 15, 2025

Study Registration Dates

First Submitted

February 25, 2025

First Submitted That Met QC Criteria

March 3, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 3, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIETA-MICIREUMA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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