- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05719402
Quantitative Assessment of Intestinal Motility on Bowel Ultrasound in Patients With Inflammatory Bowel Disease: a Feasibility, Observational, Cross-sectional, Monocentric Study (MOTUS)
Quantitative Assessment of Intestinal Motility on Bowel Ultrasound in Patients With Inflammatory Bowel Disease: a Feasibility, Observational, Prospective, Monocentric Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Milano, Italy, 20132
- Recruiting
- Mariangela Allocca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- > 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.
Exclusion Criteria:
- 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;
- 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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 DAY
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MOTUS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Inflammatory Bowel Diseases
-
Centre Hospitalier Universitaire, AmiensFunding from DGOS (PHRC IR 2013 and PRME)CompletedPediatric Inflammatory Bowel DiseaseFrance
-
University of British ColumbiaCompletedInflammatory Bowel Disease 11Canada
-
University of ChicagoTerminatedInflammatory Bowel Disease (IBD)United States
-
University of Wisconsin, MadisonTerminatedInflammatory Bowel Disease (IBD)United States
-
Cedars-Sinai Medical CenterUnknownPediatric Inflammatory Bowel Disease
-
Assiut UniversityNot yet recruitingIBD-Inflammatory Bowel Disease
-
University of Wisconsin, MadisonCompletedInflammatory Bowel Disease (IBD)United States
-
Icahn School of Medicine at Mount SinaiNorthwestern University; The Cleveland Clinic; University of California, Davis; RxHealt...RecruitingInflammatory Bowel Disease (IBD)United States
-
Nemours Children's ClinicNASPGHAN FoundationCompletedInflammatory Bowel Disease (IBD)United States
-
Hull University Teaching Hospitals NHS TrustWellcome/EPSRC Centre for Interventional and Surgical Sciences, University...RecruitingInflammatory Bowel Disease 1United Kingdom
Clinical Trials on non-interventional prospective cross-sectional observational study
-
University Hospital, GhentUniversity GhentCompletedOverweight and ObesityBelgium
-
Vanderbilt University Medical CenterNational Institutes of Health (NIH); National Institute of General Medical...Active, not recruitingDelirium | Critical Illness | Cognitive Impairment | Trauma | Traumatic Brain Injury | ICU | Polytrauma | Alzheimer; Early OnsetUnited States
-
Oğuzhan KandemirRecruitingFibromyalgia Syndrome | ChronotypeTurkey
-
Modum BadUniversity of OsloCompletedLoneliness, Worry, Rumination, Health Anxiety, Depression, AnxietyNorway
-
IpsenCompletedAcromegalyRussian Federation
-
University Hospital, GrenobleUnknown
-
Texas Tech UniversityCompletedGender | Early Adolescent BehaviorUnited States
-
Benha UniversityCompletedCOVID-19 | Pandemic, COVID-19 | Face Mask SqueezeEgypt
-
Aga Khan UniversityCompleted
-
University of ReadingLive UTI Free; University of BuckinghamEnrolling by invitationUrologic Diseases | Sexual Dysfunction | Patient Satisfaction | Pain, ChronicUnited Kingdom