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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Istituto Clinico Humanitas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DEVICE	LIPUS stimulation	Low Intensity Pulsed Ultrasound stimulation of the gut at the pre-clinically optimized conditions and energy dosage

Timeline

• Start date: 2024-11-01
• Primary completion: 2025-10-30
• Completion: 2026-06-30
• First posted: 2024-08-26
• Last updated: 2024-08-26