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.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-07

Study Completion Date

2025-11-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Observational Prospective Study to Identify Intestinal Microbial Profiles in Newly Diagnosed Crohn's Disease Patients

NCT06324591

Crohn Disease

ACTIVE_NOT_RECRUITING NA

Decoding Personalized Nutritional, Microbiome and Host Patterns Impacting Clinical and Prognostic Features in Crohn's Disease

NCT04283864

Crohn Disease

RECRUITING

Efficacy of CROWN in Repair and Maintenance of the Intestinal Mucosa in Patients With CD Receiving Anti-TNF Therapy

NCT02793778

Crohn's Disease

TERMINATED PHASE2

Impact of the Fecal Flora Transplantation on Crohn's Disease

NCT02097797

Crohn's Disease

COMPLETED NA

Impact of Exclusion Diet in Addition to Anti-TNF Therapy in Crohn's Disease and Ulcerative Colitis: a Prospective, Randomized, Double-arm, Open-label Study

NCT06896305

Ulcerative Colitis (UC) Crohn Disease (CD)

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Case group

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

Collecting questionnaires and biological samples

Intervention Type 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

Control group

Families with all healty components

Collecting questionnaires and biological samples

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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:

For healthy subjects:

\- Any chronic inflammatory bowel disease, autoimmune disease, or ongoing infectious diseases.

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes