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.

NCT06862843 | Recruiting

• 1 other identifier: DIETA-MICIREUMA
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Keywords

JIA; Dietary habits; CD; UC; IBD

Outcome Measures

Primary Outcomes (1)

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

  After two weeks

Secondary Outcomes (1)

• Percentage of families with microbiota alteration

  After 6 months

Study Arms (2)

Case group

Families with at least a member affected with JIA or IBD (UC or CD)

Other: Collecting questionnaires and biological samples

Control group

Families with all healty components

Other: Collecting questionnaires and biological samples

Interventions

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

Case group; Control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• For subjects affected by IBD:
• Monogenic disease
• Children with an ileostomy or who have undergone a colectomy
• For subjects affected by JIA:
• For healthy subjects:
• \- Any chronic inflammatory bowel disease, autoimmune disease, or ongoing infectious diseases.

Sponsors & Collaborators

• Meyer Children's Hospital IRCCS: lead

Study Sites (4)

AOU Meyer IRCCS

Florence, Italy, Italy

RECRUITING

Università La Sapienza di Roma

Roma, Roma, 00185, Italy

RECRUITING

Università di Foggia

Foggia, Italy

RECRUITING

Ospedale Villa Sofia Cervello, Università di Palermo

Palermo, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples Fecal samples

MeSH Terms

Conditions

Arthritis, Juvenile; Crohn Disease; Colitis, Ulcerative; Feeding Behavior

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Behavior, Animal; Behavior

Central Study Contacts

Paolo Lionetti, MD, PhD, Ordinary Professor

CONTACT

+39 3398416059; paolo.lionetti@unifi.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 6, 2025
• Study Start: February 7, 2024
• Primary Completion: May 15, 2025
• Study Completion: November 15, 2025
• Last Updated: March 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (4)