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

Launched by ISTITUTO CLINICO HUMANITAS · Aug 22, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring whether a treatment called Low Intensity Pulsed Ultrasound (LIPUS) can help patients with Ulcerative Colitis (UC) by promoting the release of tiny particles from the gut into the bloodstream. These particles might contain important information about inflammation in the intestines, which could help doctors monitor the disease and see how well treatments are working. The trial aims to find out if LIPUS can effectively release these particles during active disease and if they can be used to track therapy when patients are in remission.

To participate, individuals must be at least 18 years old and have a confirmed diagnosis of UC for at least three months. Participants should be experiencing moderate to severe symptoms and be eligible to start a new therapy. They will undergo standard procedures like endoscopy and blood tests, both before and after the LIPUS treatment. After the treatment, researchers will check in with participants to monitor for any side effects. It's important to note that there are specific criteria for who can join, including health conditions that would disqualify someone from participating.

Gender

ALL

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
• • BMI \<23.
• For Phase B:
• • male and female patients ≥ 18 years of age (at the time of signing the Informed Consent)
• • signed written Informed Consent
• • established diagnosis of UC and in clinical remission defined by partial Mayo Score with any targeted therapy
• • able to comply with the study procedures
• • BMI \<23.
• Exclusion Criteria for both phases:
• • diagnosis of indeterminate colitis, Crohn's colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis
• • absolute contraindications to colonoscopy procedures, complication during previous endoscopy
• • bleeding disorders
• • indication for surgery for UC
• • legal incapacity
• • rectal topical therapy (enemas or suppositories) ≤ 2 weeks prior to baseline
• • treatment with \> 20 mg prednisone within 3 weeks prior to baseline
• • anemia (hemoglobin \< 10 g/dl) at baseline
• • pregnant or breastfeeding women
• • women with implanted contraceptive device
• • BMI\>23
• • patients diagnosed with cancer (especially attention goes to colon-rectal neoplasty)
• • high turnover osteoporosis
• • presence of metal fragments
• • joint prostheses
• • varicous veins
• • phlebitis and thrombophlebitis
• • presence of pacemaker
• • obliterating arteriopathy
• • menstruation
• • neoplastic tissues and surrounding areas
• • tuberculosis
• • individuals in the growing phase (children and adolescents)
• • individuals not capable of communicating sense of pain
• • any circumstances which could contradict a study participation and lead the Investigator to assess the patient as unsuitable for study participation for any other reason.