A Non-Invasive Future for Ulcerative Colitis Monitoring

The ImmUniverse LIPUS Study Begins

The ImmUniverse project is studying how immune cells and tissues interact in diseases like ulcerative colitis (UC) and atopic dermatitis (AD). The goal is to determine whether certain small molecules (so called biomarkers = biological signals) found in tissues and blood can help track disease progression or improvement, ultimately leading to better diagnosis and treatment strategies.

Rethinking UC Monitoring: A Move Away from Invasive Biopsies

Currently, UC is monitored using endoscopic biopsies, which are invasive and cannot be performed frequently. This means that doctors may miss important changes in the disease between exams. To address this challenge, the ImmUniverse project is investigating Low-Intensity Pulsed Ultrasound Stimulation (LIPUS) as a non-invasive alternative for tracking disease activity.

How LIPUS Works: Harnessing Ultrasound for Biomarker Detection

LIPUS (approved already for other applications) uses gentle ultrasound waves to stimulate damaged tissues, encouraging the release of micro-vesicles and molecules (biomarkers). These biomarkers can enter the bloodstream, providing valuable information about the level of inflammation in the gut. Scientists believe that, if LIPUS can reliably trigger these biomarkers, doctors could eventually monitor UC with a simple blood test instead of an invasive biopsy.

From Mice to Humans: Early Findings and Scientific Validation

So far, ImmUniverse researchers tested LIPUS in mice with colitis demonstrating the complete safety of the approach and identifying the optimum LIPUS application conditions to elicit the release of specific microRNAs (miRNAs) and small molecules reflecting inflammation. The application of the approach on samples from UC patients confirmed the ability of LIPUS to promote the release of miRNAs that correlate with relevant clinical parameters useful for monitoring disease activity.

A Milestone in UC Research: The First Clinical Trial with LIPUS in ImmUniverse

The first clinical study using LIPUS on patients with ulcerative colitis has been approved by the Ethical Committee and the Italian Ministry of Health. This trial will begin in March 2025 at Humanitas Research Hospital and San Raffaele Hospital in Milan, Italy, led by Dr Alessandro Armuzzi and Dr Silvio Danese, two internationally recognized experts in inflammatory bowel diseases.

What’s Next? Study Timeline, and Goals

Study Details
Duration: March 2025 - April 2026
Number of Participants: 90 patients, divided into two study phases
Recruitment Sites: Humanitas Research Hospital (HUMANITAS), Milan
IRCCS Ospedale San Raffaele, Milan
Study Phases:
Phase A (Pilot Study): 30 UC patients with active disease, not yet on therapy, and 10 healthy volunteers.
Phase B (Pivotal Study): 50 UC patients in remission, undergoing targeted therapy.

Goals of the Study
Primary Goal: To assess whether LIPUS can effectively stimulate the release of small molecules into the bloodstream, reflecting the inflammatory state of the intestinal lining.
Secondary Goal: To evaluate whether these small molecules can help monitor treatment response.