The Role of Intestinal Ultrasound in Monitoring the Response to Biological Therapy in Patients With Ulcerative Colitis

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05606939
Collaborator
(none)
100
14.3

Study Details

Study Description

Brief Summary

In this study, the investigators aim to evaluate the role of intestinal ultrasound in evaluation of the therapeutic response to biological therapy in patient with ulcerative colitis

Condition or Disease Intervention/Treatment Phase
  • Device: intestinal ultrasound

Detailed Description

Ultrasound examination is an easily accessible, non-invasive, radiation-free technique, and cheap imaging modality that is often chosen as the first diagnostic method in gastroenterology disease.

performance of bowel ultrasound use of two different probes: low-frequency convex probe (3.0-3.5 MHz) and high-frequency linear probe (5-17 MHz) .

Inflammatory bowel disease (IBD) is a chronic inflammatory disease of the gastrointestinal tract, which clinically contains Crohn's disease, ulcerative colitis, and other conditions. IBD is characterized by episodes of abdominal pain, diarrhea, bloody stools, weight loss, and the influx of neutrophils and macrophages that produce cytokines, proteolytic enzymes

Intestinal ultrasound has been shown to have high sensitivity and specificity in the detection or exclusion of intestinal inflammatory activity in IBD. advantages of intestinal ultrasound over other imaging modalities include non-invasiveness, rapid availability and low costs ,evaluation of bowel wall thickness, as well as stratification that reflects alterations in histopathology ulcerative colitis (UC). Visualization of the vascularization of the bowel using color Doppler sonography and, direct visualization of motility.

A study done : IUS is preferred for monitoring the disease course and for assessing short-term treatment response. Found that monitoring bowel wall thickening (BWT) alone has the potential to predict the therapeutic response.The primary therapeutic goal in UC is to induce and maintain long-term disease remission; however, there is no single treatment pathwayguidelines recommend the use of either conventional therapies (i.e., aminosalicylates ..etc)Or the use of biologic therapies ( infliximab.)

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Role of Intestinal Ultrasound in Monitoring the Response to Biological Therapy in Patients With Ulcerative Colitis
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Mar 12, 2024

Outcome Measures

Primary Outcome Measures

  1. the role of intestinal ultrasound in evaluation of the therapeutic response to biological therapy in patient with ulcerative colitis [Baseline , 2 weeks , 6 weeks]

    All patients will be evaluated using intestinal ultrasound with special emphasis on intestinal wall thickness in mm as well as stratification normal or dirupted and Visualization of the vascularization (normal decrease or increased) of the bowel using color Doppler sonography also visualization of motility (normal , increased or decreaed) Findings of intestinal ultrasound will be compared regrading colonoscopic findings to evaluate the response to biological therapy through IUS

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  • Any patient above age of 18 years old and diagnosed to have UC and whom not responding to conventional medical therapy and eligible for biological therapy will be recruited in this study

  • moderate to severe UC patients

  • immunosuppressant or corticosteroid refractory disease

  • those with intolerance or contraindication to conventional therapies are eligible to be treated with biological therapy

Exclusion Criteria:
  • Patients with UC who are under age of 18 years' old

  • Patients with UC who aren't eligible to biological therapy

  • patients with complication of UC(fistula , intestinal obstruction , intestinal perforation ,……)

  • Patient refuse to participate in the study.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Abanoub Ayoub Melk, resident doctor at tropical medicine and gastroenterology, Assiut University
ClinicalTrials.gov Identifier:
NCT05606939
Other Study ID Numbers:
  • IUS in ulcerative colitis
First Posted:
Nov 7, 2022
Last Update Posted:
Nov 7, 2022
Last Verified:
Oct 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 7, 2022