Ulcerative Colitis Chronic ModerateNCT05735665
Comparison Between Bowel Ultrasound-based Treat to Target Versus Routine Treat to Target Strategies in Ulcerative Colitis
A study testing bowel ultrasound and colonoscopy in people with Ulcerative Colitis Chronic Moderate and Ulcerative Colitis Chronic Severe, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
UC (UC) is a chronic, relapsing and destructive inflammatory disorder of the colon which can lead to organ damage and impair quality of life. Consensus guidelines recommend to go beyond resolution of clinical symptoms and achieve endoscopic remission. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis Chronic Moderate, Ulcerative Colitis Chronic Severe
- What is being tested?
- bowel ultrasound and colonoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteItaly
- Study dates
- 3 Oct 2022to Jan 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Established diagnosis of UC since at least 8 weeks prior to inclusion
- Age ≥ 18 years
- Any gender/sex
- Active disease consistent with indication to start with systemic corticosteroids, biological agents or small molecules (defined as a patient-reported outcomes score, PRO > 2)
- Ability to understand and to comply with the study procedure and sign an informed consent form
Who cannot join
- Subjects with inflammation restricted to the rectum (≤ 15 cm from the anal verge);
- Subjects with severe UC (defined as a Mayo global score > 12, requiring hospitalization);
- Subjects with an endoscopic Mayo sub-score at baseline <2;
- Subjects with a MUC at baseline < 6.2;
- Pregnancy
- Subjects with any contraindication to any study procedure.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Mariangela Allocca
Milan, 20132
MARIANGELA ALLOCCA, 0226432069, allocca.mariangela@hsr.it
About this study
UC (UC) is a chronic, relapsing and destructive inflammatory disorder of the colon which can lead to organ damage and impair quality of life.
Consensus guidelines recommend to go beyond resolution of clinical symptoms and achieve endoscopic remission. This long-term treatment goal in UC is commonly defined by a Mayo endoscopic subscore < 13, and is associated with prolonged clinical remission, lower rates of hospitalization and lower rates of colectomy. However, colonoscopy is an invasive and expensive procedure, unpleasant to patients, not without risks, especially during severe flares. Moreover, CS is time-consuming and expensive for the Healthcare System.
Read more
Clinical symptoms correlate well with endoscopic findings, and their improvement together to normalization of FC, are currently considered the short-term and intermediate-term targets to achieve. However, while asymptomatic patients with FC < 50 mcg/g have < 5% probability to have endoscopic lesions, and conversely patients with evident rectal bleeding and persistent increased stool frequency (> 3 stools above baseline) with FC > 250 mcg/g have less than 5% chance to have endoscopic remission, in patients in the intermediate scenarios with stool frequency score (SFS) 2 or 3 or rectal bleeding score (RBS) > 0, with FC values between 50 and 250 mcg/g, the uncertainty increases and CS should not be avoided.
Bowel US is a well-tolerated, non-invasive, patient friendly, cheap, easy-to-use tool to manage UC patients in clinical practice8. In addition, its ability to be performed as point-of-care bowel US may drastically change frequency of the assessment of treatment response, speeding the clinical decision-making process9. Recently, the investigators developed and externally validated non-invasive ultrasonography based criteria [Milan ultrasound criteria (MUC)] to assess and grade endoscopic activity in UC10,11. The investigators also confirmed that a MUC score > 6.2 is a valid cut-off to discriminate endoscopic activity, defined by a Mayo endoscopic subscore > 1 Bowel US is a well-tolerated, non-invasive, patient friendly, cheap, easy-to-use tool to manage UC patients in clinical practice. In addition, its ability to be performed as point-of-care bowel US may drastically change frequency of the assessment of treatment response, speeding the clinical decision-making process. Recently, the investigators developed and externally validated non-invasive ultrasonography based criteria [Milan ultrasound criteria (MUC)] to assess and grade endoscopic activity in UC14,15. The investigators also confirmed that a MUC score > 6.2 is a valid cut-off to discriminate endoscopic activity, defined by a Mayo endoscopic subscore > 1.
Read the detailed description
Prospective interventional randomized open-label study to validate the role of US-based treat-to-target strategies in the decision-making process in patients with UC.
Patients seen at each participating center who are eligible for this study will be randomized 1:1 (computer generated randomization list) to enter one of two study arms up to Week 52:
- study group: the bowel US-based treat to target arm
- control group: the routine CS treat to target arm. At Week 52 ± 4, all patients in the two study arms will undergo CS, bowel US, PRO and FC as indicated for the screening phase.
Patients will be followed up and will undergo the study procedures as described below:
Bowel Ultrasound-based Treat to target arm At W12 ± 4 and W24 ± 4, subjects will perform FC and bowel US and PRO will be recorded.
If rectal bleeding > 2 + stool frequency > 2 AND FC > 250 mcg/g AND/OR MUC > 6.2, treatment will be changed according to the standard of care and international guidelines.
Routine CS Treat to target arm At W12 ± 4 and W24 ± 4, subjects will perform FC and PRO will be recorded for all patients.
If rectal bleeding > 2 + stool frequency > 2 AND FC > 250 mcg/g, treatment will be changed according to the standard of care and guidelines. If rectal bleeding > 0 + stool frequency > 2 AND FC will be ≥ 50 mcg/g and ≤ 250 mcg/g, a RSS will be done in order to decide any treatment switch.
The routine CS treat-to-target arm schedule is based on the recommendations of the STRIDE II. When appropriate, based on the investigator's judgement, CS can be replaced by a RSS.
Since the two strategies are part of the standards of care, no additional procedures outside the current clinical practice will be used in this study.
- Being tested
- bowel ultrasound, colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bowel ultrasoundDiagnostic test
Bowel US is a non-invasive tool which is able to measure intestinal inflammation by the use of emission of US from a specific probe. It is used externally, just moving the probe on the skin of the patient along the abdominal section. It does not require any contrast. The preparation used is just a fasting period of 6 hours.
colonoscopyDiagnostic test
Colonoscopy is an endoscopic procedure where a tube is inserted from the anus up to the ileum of the patient. It requires bowel cleansing with polyethilenglicole up to 4 liters (depending on the preparation and the desired grade of cleansing) the day before the examination. Because it may be painful, usually sedation is provided.
| Study group | Role | What they receive |
|---|---|---|
| study group: the bowel Ultrasound-based treat to target arm | Experimental | At W12 ± 4 and W24 ± 4, subjects will perform FC and bowel US and PRO will be recorded.
If rectal bleeding > 2 + stool frequency > 2 AND FC > 250 mcg/g AND/OR MUC > 6.2, treatment will be changed according to GCP and international guidelines. Receives: Diagnostic Test: bowel ultrasound |
| control group: the routine Colonoscopy treat to target arm. | Other | At W12 ± 4 and W24 ± 4, subjects will perform FC and PRO will be recorded for all patients.
If rectal bleeding > 2 + stool frequency > 2 AND FC > 250 mcg/g, treatment will be changed according to GCP and international guidelines. If rectal bleeding > 0 + stool frequency > 2 AND FC will be ≥ 50 mcg/g and ≤ 250 mcg/g, a RSS will be done in order to decide any treatment switch. Receives: Diagnostic Test: colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to evaluate the two strategies in terms of efficacy of bowel US-based strategy versus CS-based strategy in terms of remission.
Remission will be defined as global Mayo Score at week 52
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start3 Oct 2022
- Primary completionJun 2023 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis Chronic ModerateStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariangela Allocca, IRCCS San Raffaele
- Investigators
- MARIANGELA ALLOCCA, Principal investigator, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05735665
- Sponsor's protocol ID
- T2T
- Status last verified
- Jan 2023
- First submitted
- 27 Jan 2023
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Bowel Ultrasound-based Treat to Target Versus Routine Treat to Target Strategies in Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT05735665
- Acronym / sponsor ID
- T2T
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 21 Feb 2023 (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.
UC (UC) is a chronic, relapsing and destructive inflammatory disorder of the colon which can lead to organ damage and impair quality of life.
Consensus guidelines recommend to go beyond resolution of clinical symptoms and achieve endoscopic remission. This long-term treatment goal in UC is commonly defined by a Mayo endoscopic subscore < 13, and is associated with prolonged clinical remission, lower rates of hospitalization and lower rates of colectomy. However, colonoscopy is an invasive and expensive procedure, unpleasant to patients, not without risks, especially during severe flares. Moreover, CS is time-consuming and expensive for the Healthcare System.
Clinical symptoms correlate well with endoscopic findings, and their improvement together to normalization of FC, are currently considered the short-term and intermediate-term targets to achieve. However, while asymptomatic patients with FC < 50 mcg/g have < 5% probability to have endoscopic lesions, and conversely patients with evident rectal bleeding and persistent increased stool frequency (> 3 stools above baseline) with FC > 250 mcg/g have less than 5% chance to have endoscopic remission, in patients in the intermediate scenarios with stool frequency score (SFS) 2 or 3 or rectal bleeding score (RBS) > 0, with FC values between 50 and 250 mcg/g, the uncertainty increases and CS should not be avoided.
Bowel US is a well-tolerated, non-invasive, patient friendly, cheap, easy-to-use tool to manage UC patients in clinical practice8. In addition, its ability to be performed as point-of-care bowel US may drastically change frequency of the assessment of treatment response, speeding the clinical decision-making process9. Recently, the investigators developed and externally validated non-invasive ultrasonography based criteria [Milan ultrasound criteria (MUC)] to assess and grade endoscopic activity in UC10,11. The investigators also confirmed that a MUC score > 6.2 is a valid cut-off to discriminate endoscopic activity, defined by a Mayo endoscopic subscore > 1 Bowel US is a well-tolerated, non-invasive, patient friendly, cheap, easy-to-use tool to manage UC patients in clinical practice. In addition, its ability to be performed as point-of-care bowel US may drastically change frequency of the assessment of treatment response, speeding the clinical decision-making process. Recently, the investigators developed and externally validated non-invasive ultrasonography based criteria [Milan ultrasound criteria (MUC)] to assess and grade endoscopic activity in UC14,15. The investigators also confirmed that a MUC score > 6.2 is a valid cut-off to discriminate endoscopic activity, defined by a Mayo endoscopic subscore > 1.
Detailed description
Prospective interventional randomized open-label study to validate the role of US-based treat-to-target strategies in the decision-making process in patients with UC.
Patients seen at each participating center who are eligible for this study will be randomized 1:1 (computer generated randomization list) to enter one of two study arms up to Week 52:
- study group: the bowel US-based treat to target arm
- control group: the routine CS treat to target arm. At Week 52 ± 4, all patients in the two study arms will undergo CS, bowel US, PRO and FC as indicated for the screening phase.
Patients will be followed up and will undergo the study procedures as described below:
Bowel Ultrasound-based Treat to target arm At W12 ± 4 and W24 ± 4, subjects will perform FC and bowel US and PRO will be recorded.
If rectal bleeding > 2 + stool frequency > 2 AND FC > 250 mcg/g AND/OR MUC > 6.2, treatment will be changed according to the standard of care and international guidelines.
Routine CS Treat to target arm At W12 ± 4 and W24 ± 4, subjects will perform FC and PRO will be recorded for all patients.
If rectal bleeding > 2 + stool frequency > 2 AND FC > 250 mcg/g, treatment will be changed according to the standard of care and guidelines. If rectal bleeding > 0 + stool frequency > 2 AND FC will be ≥ 50 mcg/g and ≤ 250 mcg/g, a RSS will be done in order to decide any treatment switch.
The routine CS treat-to-target arm schedule is based on the recommendations of the STRIDE II. When appropriate, based on the investigator's judgement, CS can be replaced by a RSS.
Since the two strategies are part of the standards of care, no additional procedures outside the current clinical practice will be used in this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group: the bowel Ultrasound-based treat to target arm | Experimental | Diagnostic Test: bowel ultrasoundAt W12 ± 4 and W24 ± 4, subjects will perform FC and bowel US and PRO will be recorded. If rectal bleeding > 2 + stool frequency > 2 AND FC > 250 mcg/g AND/OR MUC > 6.2, treatment will be changed according to GCP and international guidelines. |
| control group: the routine Colonoscopy treat to target arm. | Other | Diagnostic Test: colonoscopyAt W12 ± 4 and W24 ± 4, subjects will perform FC and PRO will be recorded for all patients. If rectal bleeding > 2 + stool frequency > 2 AND FC > 250 mcg/g, treatment will be changed according to GCP and international guidelines. If rectal bleeding > 0 + stool frequency > 2 AND FC will be ≥ 50 mcg/g and ≤ 250 mcg/g, a RSS will be done in order to decide any treatment switch. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Established diagnosis of UC since at least 8 weeks prior to inclusion
- Age ≥ 18 years
- Any gender/sex
- Active disease consistent with indication to start with systemic corticosteroids, biological agents or small molecules (defined as a patient-reported outcomes score, PRO > 2)
- Ability to understand and to comply with the study procedure and sign an informed consent form
Key exclusion criteria (6 listed)
- Subjects with inflammation restricted to the rectum (≤ 15 cm from the anal verge);
- Subjects with severe UC (defined as a Mayo global score > 12, requiring hospitalization);
- Subjects with an endoscopic Mayo sub-score at baseline <2;
- Subjects with a MUC at baseline < 6.2;
- Pregnancy
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 |
|---|---|---|
| bowel ultrasoundBowel US is a non-invasive tool which is able to measure intestinal inflammation by the use of emission of US from a specific probe. It is used externally, just moving the probe on the skin of the patient along the abdominal section. It does not require any contrast. The preparation used is just a fasting period of 6 hours. | Diagnostic test | study group: the bowel Ultrasound-based treat to target arm |
| colonoscopyColonoscopy is an endoscopic procedure where a tube is inserted from the anus up to the ileum of the patient. It requires bowel cleansing with polyethilenglicole up to 4 liters (depending on the preparation and the desired grade of cleansing) the day before the examination. Because it may be painful, usually sedation is provided. | Diagnostic test | control group: the routine Colonoscopy treat to target arm. |
Primary outcome
The primary objective is to evaluate the two strategies in terms of efficacy of bowel US-based strategy versus CS-based strategy in terms of remission.
Time frame: 2 years
Remission will be defined as global Mayo Score at week 52
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
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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.
MARIANGELA ALLOCCA principal investigator
IRCCS San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bowel ultrasound and colonoscopy in people with Ulcerative Colitis Chronic Moderate and Ulcerative Colitis Chronic Severe, run by IRCCS San Raffaele at 1 site in Italy.
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 5 inclusion and 6 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 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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 MARIANGELA ALLOCCA (02 2643 2069, allocca.mariangela@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective is to evaluate the two strategies in terms of efficacy of bowel US-based strategy versus CS-based strategy in terms of remission. (time frame: 2 years). 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 21 Feb 2023.