Status:
NOT_YET_RECRUITING
From Nature to Bedside- Algae Based Bio Compound for Prevention and Treatment of Inflammation, Pain and IBD
Lead Sponsor:
IRCCS San Raffaele
Conditions:
IBD
Eligibility:
All Genders
18-60 years
Brief Summary
This study is part of the project funded by the Horizon2020 program for establishing the consortium Algae4IBD (https://algae4ibd.eu/), where OSR participates as a partner. It aims to promote the imple...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- SUBJECTS WITH THE DIAGNOSIS OF UC OR CD:
- subjects undergoing endoscopy and biopsies collection per standard of care
- adult patients ≥18 and \<60 years
- Additionally, for people with UC:
- \- clinical and endoscopic evaluation (Mayo score≥2)
- Additionally, for individuals with CD:
- \- clinical and endoscopic evaluation (Harvey-Bradshaw score ≥5 and overall simplified endoscopic score (SES-CD) \>2)
- SUBJECTS NOT AFFECTED BY UC OR CD:
- subjects undergoing endoscopy and biopsies collection (≥18 and \<60 years) according to the normal clinical practice (as patients undergoing cancer surveillance, irritable bowel syndrome (IBS), diarrhea)
- subjects not affected by UC or CD according to the previously reported clinical and endoscopic evaluation criteria All patients will sign the informed consent.
- EXCLUSION CRITERIA
- SUBJECTS WITH THE DIAGNOSIS OF UC OR CD:
- \- subjects with UC or CD who do not have the previously described clinical and endoscopic evaluation criteria
- SUBJECTS NOT AFFECTED BY UC OR CD (CONTROL GROUP):
- subjects undergoing anti-inflammatory and/or immunosuppressive treatments for other diseases not related to UC or CD
Exclusion
Key Trial Info
Start Date :
November 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06042582
Start Date
November 1 2023
End Date
May 1 2026
Last Update
September 18 2023
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