Juvenile Idiopathic Arthritis (JIA)DIETA-MICIREUMNCT06862843
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.
An observational study of Juvenile Idiopathic Arthritis (JIA) and Crohn Disease (CD), run by Meyer Children's Hospital IRCCS at 4 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Juvenile Idiopathic Arthritis (JIA), Crohn Disease (CD), Ulcerative Colitis (UC)
- What is being tested?
- Collecting questionnaires and biological samples
- How many people
- 90 participants
- Where
- 4 sitesItaly
- Study dates
- 7 Feb 2024to 15 Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy4 sites, 4 recruiting
- Recruiting
AOU Meyer IRCCS
Florence, Italy
Paolo Lionetti, MD, PhD, Ordinary Professor, +39 3398416059, paolo.lionetti@unifi.it
- Recruiting
Università di Foggia
Foggia
Angelo Campanozzi, MD, angelo.campanozzi@unifg.it
- Recruiting
Ospedale Villa Sofia Cervello, Università di Palermo
Palermo
Fabio Macaluso, fsmacaluso@gmail.com
- Recruiting
Università La Sapienza di Roma
Roma, Roma, 00185
Marina Aloi, MD, marina.aloi@uniroma1.it
About this study
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.
- Being tested
- Collecting questionnaires and biological samples
- Keywords
- JIA, Dietary habits, CD, UC, IBD
- Medical subject headings
- Arthritis, Juvenile, Crohn Disease, Colitis, Ulcerative, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collecting questionnaires and biological samplesOther
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
| Study group | Role | What they receive |
|---|---|---|
| Case group | Families with at least a member affected with JIA or IBD (UC or CD) Receives: Other: Collecting questionnaires and biological samples | |
| Control group | Families with all healty components Receives: Other: Collecting questionnaires and biological samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-days food diary, kidmed and medi-lite scores
Measured: After two weeks
Secondary outcomes (1)
Percentage of families with microbiota alteration
Measured: After 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start7 Feb 2024
- Primary completion15 May 2025 (estimated)
- Study completion15 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Idiopathic Arthritis (JIA)Studies of the same condition, open and under way.
- More trials run by Meyer Children's Hospital IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meyer Children's Hospital IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Lionetti, Meyer Children's Hospital IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06862843
- Sponsor's protocol ID
- DIETA-MICIREUMA
- Acronym
- DIETA-MICIREUM
- Status last verified
- Feb 2025
- First submitted
- 25 Feb 2025
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- DIETA-MICIREUM / DIETA-MICIREUMA
- Keywords
- JIA, Dietary habits, CD, UC, IBD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Meyer Children's Hospital IRCCSUniversity, hospital or other
- Study start
- 7 Feb 2024 (actual)
- Primary completion
- 15 May 2025 (estimated)
- Study completion
- 15 Nov 2025 (estimated)
- First posted
- 6 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | – | Other: Collecting questionnaires and biological samplesFamilies with at least a member affected with JIA or IBD (UC or CD) |
| Control group | – | Other: Collecting questionnaires and biological samplesFamilies with all healty components |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
- 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.
Key exclusion criteria (7 listed)
- Monogenic disease
- Children with an ileostomy or who have undergone a colectomy
- No exclusion criteria
- Any chronic inflammatory bowel disease, autoimmune disease, or ongoing infectious diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collecting questionnaires and biological samplesFor 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 | Other | Case group, Control group |
Primary outcome
3-days food diary, kidmed and medi-lite scores
Time frame: After two weeks
1 secondary outcome
Percentage of families with microbiota alteration
Time frame: After 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Juvenile Idiopathic Arthritis (JIA) and Crohn Disease (CD), run by Meyer Children's Hospital IRCCS at 4 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paolo Lionetti, MD, PhD, Ordinary Professor (+39 3398416059, paolo.lionetti@unifi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-days food diary, kidmed and medi-lite scores (time frame: After two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.