Crohn'sUCRecruiting
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.
Observational · No treatment assigned · 4 sites · Meyer Children's Hospital IRCCS
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Juvenile Idiopathic Arthritis (JIA), Crohn Disease (CD) and Ulcerative Colitis (UC). This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Age range not stated in the record
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- 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.
Plus 2 more requirement(s). There are also 7 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 90 participants are expected to take part.
- Start date: 2024-02-07.
- Main results expected around 2025-05-15 (estimate from the record).
- 4 study sites listed (4 marked recruiting) in Italy.
Main thing being measured
- 3-days food diary, kidmed and medi-lite scores (After two weeks)
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Juvenile Idiopathic Arthritis (JIA); Crohn Disease (CD); Ulcerative Colitis (UC) |
| Lead sponsor | Meyer Children's Hospital IRCCS |
| Enrollment | 90 (estimated) |
| Start date | 2024-02-07 |
| Primary completion (est.) | 2025-05-15 |
| First posted | 2025-03-06 |
| Last updated | 2025-03-06 |
| Official title | 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. |
| ClinicalTrials.gov ID | NCT06862843 |
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
Full eligibility criteria (from the record)
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.
Locations (4)
| Site | City | Country | Site status |
|---|---|---|---|
| Università di Foggia | Foggia | Italy | Recruiting |
| Ospedale Villa Sofia Cervello, Università di Palermo | Palermo | Italy | Recruiting |
| AOU Meyer IRCCS | Florence, Italy | Italy | Recruiting |
| Università La Sapienza di Roma | Roma, Roma | Italy | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.