Status:
UNKNOWN
Machine Learning Approach to Study the Interactions Between Environment and Intestinal Tissue Homeostasis in IBD
Lead Sponsor:
IRCCS San Raffaele
Conditions:
Diabetes Mellitus, Type 1
Ulcerative Colitis
Eligibility:
All Genders
Brief 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 nutrien...
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 ...
Eligibility Criteria
Inclusion
- 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)
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06120322
Start Date
November 1 2023
End Date
November 1 2025
Last Update
November 7 2023
Active Locations (1)
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1
IRCCS Ospedale San Raffaele
Milan, Italy