Ulcerative ColitisLIPUSinVIVONCT06569888
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
A study testing LIPUS stimulation in people with Ulcerative Colitis, run by Istituto Clinico Humanitas.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- LIPUS stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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:
Read more
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
- Being tested
- LIPUS stimulation
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIPUS stimulationDevice
Low Intensity Pulsed Ultrasound stimulation of the gut at the pre-clinically optimized conditions and energy dosage
| Study group | Role | What they receive |
|---|---|---|
| LIPUS stimulation | Experimental | LIPUS stimulation supplying the pre-clinically optimized energy dosage and conditions Receives: Device: LIPUS stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Identification of extracellular vesicle molecular content before and after LIPUS stimulation which correlate with intestinal inflammation in Ulcerative Colitis (active/remission states) by fluorescent miRNA microarray technology and RNA-seq
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start1 Nov 2024 (estimated)
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Collaborators
- Innovative Medicines Initiative, Ospedale San Raffaele
- Responsible party
- Sponsor
- Investigators
- Alessandro Armuzzi, MD, Principal investigator, Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06569888
- Sponsor's protocol ID
- IBD-2022-001
- Acronym
- LIPUSinVIVO
- Status last verified
- Aug 2024
- First submitted
- 29 Jul 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06569888
- Acronym / sponsor ID
- LIPUSinVIVO / IBD-2022-001
- Conditions
- Ulcerative Colitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Collaborators
- Innovative Medicines Initiative, Ospedale San Raffaele
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LIPUS stimulation | Experimental | Device: LIPUS stimulationLIPUS stimulation supplying the pre-clinically optimized energy dosage and conditions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LIPUS stimulationLow Intensity Pulsed Ultrasound stimulation of the gut at the pre-clinically optimized conditions and energy dosage | Device | LIPUS stimulation |
Primary outcome
Efficiency of LIPUS in terms of target-specific extracellular vesicle release
Time frame: 14 months
Evaluation of LIPUS efficiency in extracellular vesicle release by measuring extracellular vesicle concentration in blood before and after LIPUS stimulation
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alessandro Armuzzi, MD principal investigator
Istituto Clinico Humanitas
Questions about this trial
What is this clinical trial studying?
A study testing LIPUS stimulation in people with Ulcerative Colitis, run by Istituto Clinico Humanitas.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giorgio Ferrari (02 8224 2488, giorgio.ferrari@hunimed.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficiency of LIPUS in terms of target-specific extracellular vesicle release (time frame: 14 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.