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Recruiting NCT05719402

Quantitative Assessment of Intestinal Motility on Bowel Ultrasound in Patients With Inflammatory Bowel Disease: a Feasibility, Observational, Cross-sectional, Monocentric Study

Conditions: Inflammatory Bowel Diseases

Sex: All
Ages: 18 Years – N/A
Enrollment: 100
Sponsor: IRCCS San Raffaele

Location: Italy

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 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

Eligibility Criteria

Inclusion Criteria:> 18 yearsestablished diagnosis since at least 3 months requiring colonoscopy, US and histologic evaluation of tissue biopsies according to ECCO international guidelines 3-550 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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05719402). StuddyBuddy aggregates publicly available trial information.