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

NCT06569888 | Not Yet Recruiting

• 1 other identifier: IBD-2022-001
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Efficiency of LIPUS in terms of target-specific extracellular vesicle release

  Evaluation of LIPUS efficiency in extracellular vesicle release by measuring extracellular vesicle concentration in blood before and after LIPUS stimulation

  14 months

Secondary Outcomes (1)

• Accuracy of LIPUS stimulation in monitoring ulcerative colitis in terms of tissue state-specific biomarkers contained in LIPUS-induced extracellular vesicles

  14 months

Study Arms (1)

LIPUS stimulation

EXPERIMENTAL

LIPUS stimulation supplying the pre-clinically optimized energy dosage and conditions

Device: LIPUS stimulation

Interventions

LIPUS stimulation DEVICE

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

LIPUS stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead
• Innovative Medicines Initiative: collaborator
• Ospedale San Raffaele: collaborator

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Alessandro Armuzzi, MD

  Istituto Clinico Humanitas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giorgio Ferrari

CONTACT

02 8224 2488; giorgio.ferrari@hunimed.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 26, 2024
• Study Start: November 1, 2024
• Primary Completion: October 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: August 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share