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| Name | Class |
|---|---|
| Innovative Medicines Initiative | OTHER |
| Ospedale San Raffaele | OTHER |
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The goal of this clinical trial is to learn whether Low Intensity Pulsed Ultrasound (LIPUS) is capable of promoting the release of extracellular vesicles from the gut into the bloodstream of Ulcerative Colitis (UC) patients, whose content may be predictive of the inflammatory state of the mucosal source to aid the monitoring of the disease status and therapy response.
The main questions it aims to answer are:
Is LIPUS effective in inducing the release of biomarker-containing micro-vesicles into the bloodstream, capable of reflecting the inflammatory state of the mucosa during active disease?
Are there any extracellular vesicle-contained biomarkers that can monitor therapy during clinical remission?
Participants who undergo endoscopy and gut biopsy collection as per Standard Of Care, will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LIPUS stimulation | Experimental | LIPUS stimulation supplying the pre-clinically optimized energy dosage and conditions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LIPUS stimulation | Device | Low Intensity Pulsed Ultrasound stimulation of the gut at the pre-clinically optimized conditions and energy dosage |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficiency of LIPUS in terms of target-specific extracellular vesicle release | Evaluation of LIPUS efficiency in extracellular vesicle release by measuring extracellular vesicle concentration in blood before and after LIPUS stimulation | 14 months |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of LIPUS stimulation in monitoring ulcerative colitis in terms of tissue state-specific biomarkers contained in LIPUS-induced extracellular vesicles | Identification of extracellular vesicle molecular content before and after LIPUS stimulation which correlate with intestinal inflammation in Ulcerative Colitis (active/remission states) by fluorescent miRNA microarray technology and RNA-seq |
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Inclusion Criteria:
For Phase A:
For Phase B:
Exclusion Criteria for both phases:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giorgio Ferrari | Contact | 02 8224 2488 | giorgio.ferrari@hunimed.eu |
| Name | Affiliation | Role |
|---|---|---|
| Alessandro Armuzzi, MD | Istituto Clinico Humanitas | Principal Investigator |
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| 14 months |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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