Inflammatory Bowel DiseasesMOTUSNCT05719402
Quantitative Assessment of Intestinal Motility on Bowel Ultrasound in Patients With Inflammatory Bowel Disease: a Feasibility, Observational, Cross-sectional, Monocentric Study
An observational study of Inflammatory Bowel Diseases, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
Inflammatory bowel diseases (IBD), such as ulcerative colitis (UC) and Crohn's disease (CD), are chronic, relapsing and destructive inflammatory disorder of the intestinal wall. A treat-to-target approach with tight monitoring of intestinal inflammatory lesions is recommended to prevent organ damage and impaired… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- non-interventional prospective cross-sectional observational study
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 15 Dec 2022to 25 Nov 2024
- Phase
- Observational
- 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
Study population: 100 adult IBD patients (established diagnosis since at least 3months) at the Gastroenterology Department of the San Raffaele Hospital requiring colonoscopy, US and histologic evaluation of tissue biopsies according to ECCO international guidelines
Who may be able to join
- > 18 years
- established diagnosis since at least 3 months requiring colonoscopy, US and histologic evaluation of tissue biopsies according to ECCO international guidelines 3-5
- 50 CD ileo-colonic patients, 25 in endoscopic activity (as defined by a SES-CD > 2), 25 in endoscopic remission (as defined by a SES-CD < 2), independently from treatment;
- 50 UC patients, 25 in endoscopic activity (as defined by a Mayo endoscopic score > 2), 25 in endoscopic remission (as defined by a Mayo endoscopic score < 2), independently from treatment.
Who cannot join
- Patients with inflammation restricted to the rectum (≤ 15 cm from the anal verge);
- UC patients without involvement of sigmoid colon or inability to reach the sigmoid colon by CS;
- CD patients without ileal involvement or inability to reach the ileum by CS;
- Patients with severe UC (defined as a Mayo global score > 12, requiring hospitalization);
- Pregnancy;
- Previous intestinal surgery;
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- Concomitant intestinal infection (e.g. Clostridium difficile);
- Cirrhosis or intra-abdominal ascites.
- Patients not able to comply with any study procedure;
- Patients not able to understand and give informed consent form;
- Patients 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
Official title: Quantitative Assessment of Intestinal Motility on Bowel Ultrasound in Patients With Inflammatory Bowel Disease: a Feasibility, Observational, Prospective, Monocentric Study
Inflammatory bowel diseases (IBD), such as ulcerative colitis (UC) and Crohn's disease (CD), are chronic, relapsing and destructive inflammatory disorder of the intestinal wall. A treat-to-target approach with tight monitoring of intestinal inflammatory lesions is recommended to prevent organ damage and impaired quality of life. Because clinical scores and laboratory assessments have shown poor correlation with intestinal inflammation, endoscopic investigation has to be performed frequently as a reference standard. Due to the fact that colonoscopy (CS) is poorly accepted by patients, expensive, time consuming and harbors the risk of complications, new imaging strategies are required to overcome invasive procedures. The aim of this non-interventional prospective cross-sectional observational study is to investigate the feasibility of using intestinal motility quantified by intestinal ultrasound (US) to evaluate disease activity. The outcomes of intestinal motility detected by ultrasound will be compared with endoscopic and histopathological reference standards in adult patients with IBD
Read the detailed description
This is a feasibility, observational, cross-sectional, monocentric study on the evaluation of a non-invasive US approach based on the intestinal motility detection for the assessment of activity in IBD.
About 100 IBD patients under treatment at the Gastroenterology Department of the San Raffaele Hospital will be enrolled between September 2022 and September 2023. According to the observational nature of the study, all the visits and procedures described below will be performed according to the diagnostic and therapeutic assignment required by clinical practice for the patients under study. The choice of treatment will be made by the referring physicians according to the international ECCO guidelines. Therefore, the choice of assigning the patient to the diagnostic and therapeutic procedures deemed most appropriate for each case is completely independent of the study.
IBD patients will be prospectively identified and consecutively recruited. Within 7 days from the colonoscopy, patients will undergo complete clinical assessment. Harvey-Bradshaw Index (HBI) and partial Mayo score (PMS) will be calculated in Crohn's disease and in ulcerative colitis, respectively. Blood and stool samples will be obtained for C-reactive protein (CRP) and fecal calprotectin (FC) measurements.
Bowel US will be performed, in a blinded fashion, after 6-8 hour fasting, using an Aloka Arietta 750 with convex (5-1 MHz) and microconvex probes (4-8 MHz), by two expert gastroenterologists of the IBD center. Neither preparation nor contrast will be used. anonymized cineloops of the ileum segment and sigmoid colon in CD and sigmoid colon in UC, will be recorded and sent to an external cloud platform Entrolytics which is a PACS for ultrasound, for the assessment of motility through a specific software.
Any treatment will be kept stable in the interval between the two procedures. The informations obtained on the analysis of intestinal motility will not be used for therapeutic purposes on patients who will follow the therapeutic path provided by the ECCO reference guidelines.
For this reason motility analysis will not be used for clinical purposes, but for research purposes only.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- non-interventional prospective cross-sectional observational study
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-interventional prospective cross-sectional observational studyProcedure or surgery
to investigate the feasibility of using intestinal motility quantified by intestinal ultrasound (US) to evaluate disease activity. The outcomes of intestinal motility detected by ultrasound will be compared with endoscopic and histopathological reference standards in adult patients with IBD
What is being measured
The primary outcome is the main question the study is designed to answer.
outcomes of intestinal motility detected by ultrasound will be compared with endoscopic and histopathological reference standards in adult patients with IBD.
outcomes of intestinal motility detected by ultrasound will be compared with endoscopic and histopathological reference standards in adult patients with IBD.
Measured: 1 DAY
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start15 Dec 2022
- Primary completion25 Nov 2023 (estimated)
- Study completion25 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 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
- NCT05719402
- Sponsor's protocol ID
- MOTUS
- Acronym
- MOTUS
- Status last verified
- Jan 2023
- First submitted
- 27 Jan 2023
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Assessment of Intestinal Motility on Bowel Ultrasound in Patients With Inflammatory Bowel Disease: a Feasibility, Observational, Prospective, Monocentric Study
- ClinicalTrials.gov ID
- NCT05719402
- Acronym / sponsor ID
- MOTUS / MOTUS
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 25 Nov 2023 (estimated)
- Study completion
- 25 Nov 2024 (estimated)
- First posted
- 9 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.
Inflammatory bowel diseases (IBD), such as ulcerative colitis (UC) and Crohn's disease (CD), are chronic, relapsing and destructive inflammatory disorder of the intestinal wall. A treat-to-target approach with tight monitoring of intestinal inflammatory lesions is recommended to prevent organ damage and impaired quality of life. Because clinical scores and laboratory assessments have shown poor correlation with intestinal inflammation, endoscopic investigation has to be performed frequently as a reference standard. Due to the fact that colonoscopy (CS) is poorly accepted by patients, expensive, time consuming and harbors the risk of complications, new imaging strategies are required to overcome invasive procedures. The aim of this non-interventional prospective cross-sectional observational study is to investigate the feasibility of using intestinal motility quantified by intestinal ultrasound (US) to evaluate disease activity. The outcomes of intestinal motility detected by ultrasound will be compared with endoscopic and histopathological reference standards in adult patients with IBD
Detailed description
This is a feasibility, observational, cross-sectional, monocentric study on the evaluation of a non-invasive US approach based on the intestinal motility detection for the assessment of activity in IBD.
About 100 IBD patients under treatment at the Gastroenterology Department of the San Raffaele Hospital will be enrolled between September 2022 and September 2023. According to the observational nature of the study, all the visits and procedures described below will be performed according to the diagnostic and therapeutic assignment required by clinical practice for the patients under study. The choice of treatment will be made by the referring physicians according to the international ECCO guidelines. Therefore, the choice of assigning the patient to the diagnostic and therapeutic procedures deemed most appropriate for each case is completely independent of the study.
IBD patients will be prospectively identified and consecutively recruited. Within 7 days from the colonoscopy, patients will undergo complete clinical assessment. Harvey-Bradshaw Index (HBI) and partial Mayo score (PMS) will be calculated in Crohn's disease and in ulcerative colitis, respectively. Blood and stool samples will be obtained for C-reactive protein (CRP) and fecal calprotectin (FC) measurements.
Bowel US will be performed, in a blinded fashion, after 6-8 hour fasting, using an Aloka Arietta 750 with convex (5-1 MHz) and microconvex probes (4-8 MHz), by two expert gastroenterologists of the IBD center. Neither preparation nor contrast will be used. anonymized cineloops of the ileum segment and sigmoid colon in CD and sigmoid colon in UC, will be recorded and sent to an external cloud platform Entrolytics which is a PACS for ultrasound, for the assessment of motility through a specific software.
Any treatment will be kept stable in the interval between the two procedures. The informations obtained on the analysis of intestinal motility will not be used for therapeutic purposes on patients who will follow the therapeutic path provided by the ECCO reference guidelines.
For this reason motility analysis will not be used for clinical purposes, but for research purposes only.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 100 adult IBD patients (established diagnosis since at least 3months) at the Gastroenterology Department of the San Raffaele Hospital requiring colonoscopy, US and histologic evaluation of tissue biopsies according to ECCO international guidelines
Key inclusion criteria (4 listed)
- > 18 years
- established diagnosis since at least 3 months requiring colonoscopy, US and histologic evaluation of tissue biopsies according to ECCO international guidelines 3-5
- 50 CD ileo-colonic patients, 25 in endoscopic activity (as defined by a SES-CD > 2), 25 in endoscopic remission (as defined by a SES-CD < 2), independently from treatment;
- 50 UC patients, 25 in endoscopic activity (as defined by a Mayo endoscopic score > 2), 25 in endoscopic remission (as defined by a Mayo endoscopic score < 2), independently from treatment.
Key exclusion criteria (11 listed)
- Patients with inflammation restricted to the rectum (≤ 15 cm from the anal verge);
- UC patients without involvement of sigmoid colon or inability to reach the sigmoid colon by CS;
- CD patients without ileal involvement or inability to reach the ileum by CS;
- Patients with severe UC (defined as a Mayo global score > 12, requiring hospitalization);
- 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 |
|---|---|---|
| non-interventional prospective cross-sectional observational studyto investigate the feasibility of using intestinal motility quantified by intestinal ultrasound (US) to evaluate disease activity. The outcomes of intestinal motility detected by ultrasound will be compared with endoscopic and histopathological reference standards in adult patients with IBD | Procedure or surgery | – |
Primary outcome
outcomes of intestinal motility detected by ultrasound will be compared with endoscopic and histopathological reference standards in adult patients with IBD.
Time frame: 1 DAY
outcomes of intestinal motility detected by ultrasound will be compared with endoscopic and histopathological reference standards in adult patients with IBD.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 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?
An observational study of Inflammatory Bowel Diseases, 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 4 inclusion and 11 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 9 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 (0226432069, allocca.mariangela@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
outcomes of intestinal motility detected by ultrasound will be compared with endoscopic and histopathological reference standards in adult patients with IBD. (time frame: 1 DAY). 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 9 Feb 2023.