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
- Conditions
- Ulcerative Colitis
- Registration Number
- NCT06569888
- Lead Sponsor
- Istituto Clinico Humanitas
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria:<br><br>For Phase A:<br><br> - male and female patients = 18 years of age (at the time of signing the Informed<br> Consent) -signed written Informed Consent<br><br> - established diagnosis of UC with a minimum disease duration of 3 months<br><br> - moderate, moderate to severe active UC, defined by partial Mayo Score<br><br> - indication to start any targeted therapy, yet not initiated<br><br> - in case of treatment with corticosteroid: stabile dose for at least 3 weeks prior to<br> baseline, dosage = 20 mg prednisone<br><br> - indication for colonoscopy for the assessment of disease activity as for standards<br> of care and current guidelines<br><br> - able to comply with the study procedures<br><br> - BMI <23.<br><br>For Phase B:<br><br> - male and female patients = 18 years of age (at the time of signing the Informed<br> Consent)<br><br> - signed written Informed Consent<br><br> - established diagnosis of UC and in clinical remission defined by partial Mayo Score<br> with any targeted therapy<br><br> - able to comply with the study procedures<br><br> - BMI <23.<br><br>Exclusion Criteria for both phases:<br><br> - diagnosis of indeterminate colitis, Crohn's colitis, microscopic colitis, ischemic<br> colitis, infectious colitis, radiation colitis<br><br> - absolute contraindications to colonoscopy procedures, complication during previous<br> endoscopy<br><br> - bleeding disorders<br><br> - indication for surgery for UC<br><br> - legal incapacity<br><br> - rectal topical therapy (enemas or suppositories) = 2 weeks prior to baseline<br><br> - treatment with > 20 mg prednisone within 3 weeks prior to baseline<br><br> - anemia (hemoglobin < 10 g/dl) at baseline<br><br> - pregnant or breastfeeding women<br><br> - women with implanted contraceptive device<br><br> - BMI>23<br><br> - patients diagnosed with cancer (especially attention goes to colon-rectal neoplasty)<br><br> - high turnover osteoporosis<br><br> - presence of metal fragments<br><br> - joint prostheses<br><br> - varicous veins<br><br> - phlebitis and thrombophlebitis<br><br> - presence of pacemaker<br><br> - obliterating arteriopathy<br><br> - menstruation<br><br> - neoplastic tissues and surrounding areas<br><br> - tuberculosis<br><br> - individuals in the growing phase (children and adolescents)<br><br> - individuals not capable of communicating sense of pain<br><br> - any circumstances which could contradict a study participation and lead the<br> Investigator to assess the patient as unsuitable for study participation for any<br> other reason.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficiency of LIPUS in terms of target-specific extracellular vesicle release
- Secondary Outcome Measures
Name Time Method Accuracy of LIPUS stimulation in monitoring ulcerative colitis in terms of tissue state-specific biomarkers contained in LIPUS-induced extracellular vesicles