Diabetes Mellitus, Type 1NCT06120322
Machine Learning Approach to Study the Interactions Between Environment and Intestinal Tissue Homeostasis in IBD
An observational study of Diabetes Mellitus, Type 1 and Ulcerative Colitis, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
The intestinal epithelial barrier is one of the most important security checkpoints of our body that constrains harmful factors from invading mucosal surfaces and facilitates the absorption of nutrients and water. Its correct functioning is essential for maintaining gut tissue homeostasis and proper immunity. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus, Type 1, Ulcerative Colitis
- What is being tested?
- Environmental factor monitoring; collection of blood, feces and urine. For UC: collection of 8 additional biopsies
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2023to 1 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Child, Adult, Older adult
Study population: The population that will be recruited for the finalization of this study will be composed of 300 patients (250 patients with UC and 50 patients with T1D) under routine surveillance according to the normal clinical practice. Please a note for the Age Limits (Above): there are different age limits depending on the group: UC: > 18 years T1D: between 7 and 17 years
Who may be able to join
- UC:
- adult patients (>18 years)
- established diagnosis of UC (any extent)
- the disease in remission as defined by normal bowel movements/day
- no rectal bleeding
- fecal calprotectin <250 ug/g)
Show all 11Show fewer
- T1D:
- age between 7 and 17 years
- clinical diagnosis of insulin-dependent type 1 diabetes
- positivity for at least one islet autoantibody (ICA, GADA, IA-2, IAA, ZnT8)
- no more than 3 months from first insulin injection
Who cannot join
- unsigned informed consent
- celiac disease
- other intestinal inflammatory pathologies
- significant cardiac disease
- conditions associated with immune dysfunction or hematologic dyscrasia (including malignancy, lymphopenia, thrombocytopenia, or anemia)
- liver or renal dysfunction,
- tuberculosis,
- HBV, HCV, HIV, or active EBV or CMV infections
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Machine Learning Approach and IoT Technologies to Unravel the Complex Interaction Between Environmental Factors and Intestinal Tissue Homeostasis in Chronic Inflammatory Disorders: Sealing the Leaky Gut
The intestinal epithelial barrier is one of the most important security checkpoints of our body that constrains harmful factors from invading mucosal surfaces and facilitates the absorption of nutrients and water. Its correct functioning is essential for maintaining gut tissue homeostasis and proper immunity. However, such an equilibrium may be interrupted, resulting in an uncontrolled entrance of pathogenic stimuli that in turn activate a persistent gut immune response, with detrimental consequences for both local and systemic immunity. Alterations in the composition and functionality of the gut microbiome seem to be a central factor in affecting gut barrier integrity thus influencing intestinal permeability. The microbiome composition is impacted by dietary habits and environmental pollution and conditions, hygiene, genetic asset, and physical activity, which could interact in concert leading to dysbiosis, thereby influencing the immune response through the production of several metabolites. Chronic inflammatory diseases, including ulcerative colitis (UC) and type 1 diabetes (T1D), share microbiota dysbiosis, among pathologic characteristics, that may arise, be provoked, or be exacerbated because of barrier leakage. Therefore, these two chronic diseases may be considered prototype pathologies where the intrinsic connection between intestinal dysbiosis and the barrier leakage impact each other during the pathogenesis.
Read the detailed description
This is an observational multicentre study performed on patients with an established diagnosis of UC (according to the standard classification) and patients with new-onset type 1 diabetes (T1D) which aims to identify environmental and genetic factors contributing to chronic inflammation within the intestine and in peripheral organs by taking advantage of Internet-Of things (IoT) technologies (web app) and machine learning approaches. During the colonoscopy procedure planned for patients with UC following the routine surveillance according to the normal clinical practice (0 and 12 months), the gastroenterologist will collect 8 additional biopsies; furthermore, blood samples and stools for UC patients and blood samples, stools, and urines for T1D patients will be collected at baseline and during the routine surveillance according to the normal clinical practice (0, 6, and 12 months) and stored for the following analysis. For T1D patients, blood, urine and stool sample collection are not planned for the normal clinical practice, but will be performed specifically for this research proposal at different points during the normal clinical practice clinical visit: baseline, after 6 months and after 12 months.
For UC patients, blood and biopsies are collected during the procedures already planned for normal clinical practice during clinical surveillance. The investigators will take advantage of this standard of-care procedures to collect an additional volume of blood (at baseline, after 6 months and after 12 months). Therefore, patients expressing their voluntary participation in the study will be asked to give fecal samples during the routine-surveillance visit (as per the normal clinical practice) at different: at baseline, after 6 months and after 12 months.
Ospedale San Raffaele (OSR - Operative Unit (UO)1 (UO1)) is the promoter of this study. The other centers participating in the study are:
- Ospedale Casa Sollievo della Sofferenza (CSS) - Foggia (UO2)
- Azienda Ospedaliera San Camillo Forlanini - Roma (UO3) 150 subjects in total (100 patients with UC and 50 patients with T1D) will be enrolled at the IBD Center (Department of Gastroenterology and Digestive Endoscopy) and at the Pediatric Unit at Ospedale San Raffaele.
- Conditions
- Diabetes Mellitus, Type 1, Ulcerative Colitis
- Being tested
- Environmental factor monitoring; collection of blood, feces and urine. For UC: collection of 8 additional biopsies
- Medical subject headings
- Diabetes Mellitus, Type 1, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Environmental factor monitoring; collection of blood, feces and urine. For UC: collection of 8 additional biopsiesOther
During the routine surveillance according to the normal clinical practice, blood samples, feces and urines will be collected from UC patients and T1D patients (0, 6, and 12 months). Moreover, for UC patients during the surveillance sigmoidoscopy according to the normal clinical practice (or colonoscopy if the patient has more than 8 years; at the enrollment and after 12 months), colonic biopsies will be collected
| Study group | Role | What they receive |
|---|---|---|
| Ulcerative Colitis (UC) | Patients will be enrolled in all the centers participating in this study: Ospedale San Raffaele - Milano, Ospedale Casa Sollievo della Sofferenza - Foggia and Azienda Ospedaliera San Camillo Forlanini - Roma as follows: 100 UC patients at OSR, 75 at San Camillo Hospital and 75 at CSS Receives: Other: Environmental factor monitoring; collection of blood, feces and urine. For UC: collection of 8 additional biopsies | |
| Diabetes Type 1 (T1D) | 50 new onset T1D patients recruited and enrolled at OSR Receives: Other: Environmental factor monitoring; collection of blood, feces and urine. For UC: collection of 8 additional biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify the factors contributing to chronic inflammation within the intestine and in peripheral organs, in particular focusing on blood markers
Evaluation of the mmune response profile: measurement of the percentage of different immune cell populations
Measured: 1-18 months
To identify the factors contributing to chronic inflammation within the intestine and in peripheral organs, in particular focusing on feces markers
Evaluation of microbial composition of the gut: identification and quantification of different microbial species colonizing the gut
Measured: 1-18 months
To identify the factors contributing to chronic inflammation within the intestine and in peripheral organs, in particular focusing on biopsies markers
RNA extraction and transcriptomics to identify molecular variation
Measured: 1-18 months
Secondary outcomes (1)
Taking advantage of the measurements collected in Outcome 1, the investigators will use a machine learning-based multi-omics approach to easily recognize patient differences, stratification and characterization
Using MOFA, a machine learning based bioinformatics tool that comprehensively and simultaneously analyzes multiple omics and patient-specific data recorded during the follow up, the investigators could identify the origin of different clinical outcomes during the disease course, ultimately stratifying them based on environmental factors to which they were exposed and their molecular and genetic characteristics.
Measured: 19-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- 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 only
- Time perspective
- Other
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvio Danese, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06120322
- Sponsor's protocol ID
- PNRR-MAD-2022-12375729
- Status last verified
- Nov 2023
- First submitted
- 29 Sep 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Machine Learning Approach and IoT Technologies to Unravel the Complex Interaction Between Environmental Factors and Intestinal Tissue Homeostasis in Chronic Inflammatory Disorders: Sealing the Leaky Gut
- ClinicalTrials.gov ID
- NCT06120322
- Acronym / sponsor ID
- PNRR-MAD-2022-12375729
- Conditions
- Diabetes Mellitus, Type 1, Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 7 Nov 2023 (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 intestinal epithelial barrier is one of the most important security checkpoints of our body that constrains harmful factors from invading mucosal surfaces and facilitates the absorption of nutrients and water. Its correct functioning is essential for maintaining gut tissue homeostasis and proper immunity. However, such an equilibrium may be interrupted, resulting in an uncontrolled entrance of pathogenic stimuli that in turn activate a persistent gut immune response, with detrimental consequences for both local and systemic immunity. Alterations in the composition and functionality of the gut microbiome seem to be a central factor in affecting gut barrier integrity thus influencing intestinal permeability. The microbiome composition is impacted by dietary habits and environmental pollution and conditions, hygiene, genetic asset, and physical activity, which could interact in concert leading to dysbiosis, thereby influencing the immune response through the production of several metabolites. Chronic inflammatory diseases, including ulcerative colitis (UC) and type 1 diabetes (T1D), share microbiota dysbiosis, among pathologic characteristics, that may arise, be provoked, or be exacerbated because of barrier leakage. Therefore, these two chronic diseases may be considered prototype pathologies where the intrinsic connection between intestinal dysbiosis and the barrier leakage impact each other during the pathogenesis.
Detailed description
This is an observational multicentre study performed on patients with an established diagnosis of UC (according to the standard classification) and patients with new-onset type 1 diabetes (T1D) which aims to identify environmental and genetic factors contributing to chronic inflammation within the intestine and in peripheral organs by taking advantage of Internet-Of things (IoT) technologies (web app) and machine learning approaches. During the colonoscopy procedure planned for patients with UC following the routine surveillance according to the normal clinical practice (0 and 12 months), the gastroenterologist will collect 8 additional biopsies; furthermore, blood samples and stools for UC patients and blood samples, stools, and urines for T1D patients will be collected at baseline and during the routine surveillance according to the normal clinical practice (0, 6, and 12 months) and stored for the following analysis. For T1D patients, blood, urine and stool sample collection are not planned for the normal clinical practice, but will be performed specifically for this research proposal at different points during the normal clinical practice clinical visit: baseline, after 6 months and after 12 months.
For UC patients, blood and biopsies are collected during the procedures already planned for normal clinical practice during clinical surveillance. The investigators will take advantage of this standard of-care procedures to collect an additional volume of blood (at baseline, after 6 months and after 12 months). Therefore, patients expressing their voluntary participation in the study will be asked to give fecal samples during the routine-surveillance visit (as per the normal clinical practice) at different: at baseline, after 6 months and after 12 months.
Ospedale San Raffaele (OSR - Operative Unit (UO)1 (UO1)) is the promoter of this study. The other centers participating in the study are:
- Ospedale Casa Sollievo della Sofferenza (CSS) - Foggia (UO2)
- Azienda Ospedaliera San Camillo Forlanini - Roma (UO3) 150 subjects in total (100 patients with UC and 50 patients with T1D) will be enrolled at the IBD Center (Department of Gastroenterology and Digestive Endoscopy) and at the Pediatric Unit at Ospedale San Raffaele.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ulcerative Colitis (UC) | – | Other: Environmental factor monitoring; collection of blood, feces and urine. For UC: collection of 8 additional biopsiesPatients will be enrolled in all the centers participating in this study: Ospedale San Raffaele - Milano, Ospedale Casa Sollievo della Sofferenza - Foggia and Azienda Ospedaliera San Camillo Forlanini - Roma as follows: 100 UC patients at OSR, 75 at San Camillo Hospital and 75 at CSS |
| Diabetes Type 1 (T1D) | – | Other: Environmental factor monitoring; collection of blood, feces and urine. For UC: collection of 8 additional biopsies50 new onset T1D patients recruited and enrolled at OSR |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The population that will be recruited for the finalization of this study will be composed of 300 patients (250 patients with UC and 50 patients with T1D) under routine surveillance according to the normal clinical practice. Please a note for the Age Limits (Above): there are different age limits depending on the group: UC: > 18 years T1D: between 7 and 17 years
Key inclusion criteria (11 listed)
- adult patients (>18 years)
- established diagnosis of UC (any extent)
- the disease in remission as defined by normal bowel movements/day
- no rectal bleeding
- fecal calprotectin <250 ug/g)
Key exclusion criteria (8 listed)
- unsigned informed consent
- celiac disease
- other intestinal inflammatory pathologies
- significant cardiac disease
- conditions associated with immune dysfunction or hematologic dyscrasia (including malignancy, lymphopenia, thrombocytopenia, or anemia)
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 |
|---|---|---|
| Environmental factor monitoring; collection of blood, feces and urine. For UC: collection of 8 additional biopsiesDuring the routine surveillance according to the normal clinical practice, blood samples, feces and urines will be collected from UC patients and T1D patients (0, 6, and 12 months). Moreover, for UC patients during the surveillance sigmoidoscopy according to the normal clinical practice (or colonoscopy if the patient has more than 8 years; at the enrollment and after 12 months), colonic biopsies will be collected | Other | Diabetes Type 1 (T1D), Ulcerative Colitis (UC) |
Primary outcome
To identify the factors contributing to chronic inflammation within the intestine and in peripheral organs, in particular focusing on blood markers
Time frame: 1-18 months
Evaluation of the mmune response profile: measurement of the percentage of different immune cell populations
To identify the factors contributing to chronic inflammation within the intestine and in peripheral organs, in particular focusing on feces markers
Time frame: 1-18 months
Evaluation of microbial composition of the gut: identification and quantification of different microbial species colonizing the gut
To identify the factors contributing to chronic inflammation within the intestine and in peripheral organs, in particular focusing on biopsies markers
Time frame: 1-18 months
RNA extraction and transcriptomics to identify molecular variation
1 secondary outcome
Taking advantage of the measurements collected in Outcome 1, the investigators will use a machine learning-based multi-omics approach to easily recognize patient differences, stratification and characterization
Time frame: 19-24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Diabetes Mellitus, Type 1
Active, not recruitingObservational study
EFFECT OF HYBRID CLOSED-LOOP SYSTEMS ON CARDIOVASCULAR MARKERS IN TYPE 1 DIABETES.
Type 1 Diabetes
RecruitingObservational study
Crosstalk Between Mucosal-Associated Invariant T (MAIT) Cells and the Gut Microbiota and Mucosa in the Development of Type 1 Diabetes in Children
Type1diabetes
RecruitingPhase 2
Neoadjuvant Pembrolizumab and Porustobart in Resectable pMMR/MSS Colon Cancer
Colon Cancer
Active, not recruitingObservational study
Epidemiology of Diabetes Interventions and Complications (EDIC)
Type 1 Diabetes Mellitus
Active, not recruitingPhase 2
Islet Cell Transplant for Type 1 Diabetes
Type 1 Diabetes Mellitus
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 1 and Ulcerative Colitis, run by IRCCS San Raffaele at 1 site 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 11 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To identify the factors contributing to chronic inflammation within the intestine and in peripheral organs, in particular focusing on blood markers (time frame: 1-18 months). The study lists 3 primary outcomes in all. 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 7 Nov 2023.