Menu
Not yet recruiting 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

No phase Interventional Ulcerative Colitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LIPUS stimulation.
Who it may be relevant to
Registry conditions: Ulcerative Colitis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • Device LIPUS stimulation
    Low Intensity Pulsed Ultrasound stimulation of the gut at the pre-clinically optimized conditions and energy dosage

Primary outcome measures

  • Efficiency of LIPUS in terms of target-specific extracellular vesicle release [Time frame: 14 months]
Secondary outcome measures (1)
  • Accuracy of LIPUS stimulation in monitoring ulcerative colitis in terms of tissue state-specific biomarkers contained in LIPUS-induced extracellular vesicles [Time frame: 14 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06569888 · IBD-2022-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗