Clinical trial NCT06569888: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ulcerative Colitis
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
Collaborators: name: Innovative Medicines Initiative
name: Ospedale San Raffaele
First posted: 2024-08-26
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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


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.

Primary outcomes:
measure: Efficiency of LIPUS in terms of target-specific extracellular vesicle release
timeFrame: 14 months
Secondary outcomes:
measure: Accuracy of LIPUS stimulation in monitoring ulcerative colitis in terms of tissue state-specific biomarkers contained in LIPUS-induced extracellular vesicles
timeFrame: 14 months
Other outcomes:
Locations:
Study officials:
affiliation: Istituto Clinico Humanitas
name: Alessandro Armuzzi, MD
role: PRINCIPAL_INVESTIGATOR
References: