NCT05719402

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 27, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 9, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2024

Completed
Last Updated

February 9, 2023

Status Verified

January 1, 2023

Enrollment Period

12 months

First QC Date

January 27, 2023

Last Update Submit

January 30, 2023

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 DAY

Interventions

non-interventional prospective cross-sectional observational studyPROCEDURE

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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

You may qualify if:

  • \> 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
  • 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;
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mariangela Allocca

Milan, 20132, Italy

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Mariangela Allocca

    IRCCS San Raffaele

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariangela Allocca

CONTACT

0226432069allocca.mariangela@hsr.it

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gastroenterologist

Study Record Dates

First Submitted

January 27, 2023

First Posted

February 9, 2023

Study Start

December 15, 2022

Primary Completion

November 25, 2023

Study Completion

November 25, 2024

Last Updated

February 9, 2023

Record last verified: 2023-01

Locations

IT(1)