Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT06120322 |
Other study ID # |
PNRR-MAD-2022-12375729 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
November 1, 2023 |
Est. completion date |
November 1, 2025 |
Study information
Verified date |
November 2023 |
Source |
IRCCS San Raffaele |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical 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. 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.
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.