Utility of Low Intensity Pulsed Ultrasound Stimulation (LIPUS) to Modulate the Release of Mediators Capable of Reflecting the Inflammatory State in the Affected Colonic Tract of Ulcerative Colitis Patients
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Ulcerative Colitis
- Sponsor
- Istituto Clinico Humanitas
- Enrollment
- 90
- Primary Endpoint
- Efficiency of LIPUS in terms of target-specific extracellular vesicle release
- Status
- Not Yet Recruiting
- Last Updated
- last year
Overview
Brief Summary
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:
- undergo abdominal ultrasound to establish the distance with the target tissue and consequently set the LIPUS device to supply the optimum energy established in the protocol.
- before LIPUS stimulation and 2 hours after stimulation, patients will have blood drawn
- an extra intestinal biopsy during endoscopy will be collected
- patients will be contacted 72h after intervention for adverse events monitoring
Investigators
Eligibility Criteria
Inclusion Criteria
- •For Phase A:
- •male and female patients ≥ 18 years of age (at the time of signing the Informed Consent) -signed written Informed Consent
- •established diagnosis of UC with a minimum disease duration of 3 months
- •moderate, moderate to severe active UC, defined by partial Mayo Score
- •indication to start any targeted therapy, yet not initiated
- •in case of treatment with corticosteroid: stabile dose for at least 3 weeks prior to baseline, dosage ≤ 20 mg prednisone
- •indication for colonoscopy for the assessment of disease activity as for standards of care and current guidelines
- •able to comply with the study procedures
- •For Phase B:
- •male and female patients ≥ 18 years of age (at the time of signing the Informed Consent)
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Efficiency of LIPUS in terms of target-specific extracellular vesicle release
Time Frame: 14 months
Evaluation of LIPUS efficiency in extracellular vesicle release by measuring extracellular vesicle concentration in blood before and after LIPUS stimulation
Secondary Outcomes
- Accuracy of LIPUS stimulation in monitoring ulcerative colitis in terms of tissue state-specific biomarkers contained in LIPUS-induced extracellular vesicles(14 months)