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 (LIPUSinVIVO)

Istituto Clinico Humanitas

Status

Not yet enrolling

Conditions

Ulcerative Colitis

Treatments

Device: LIPUS stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT06569888

IBD-2022-001

Details and patient eligibility

About

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

Enrollment

90 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.