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Related Concept Videos

Inflammatory Bowel Disease IV: Pharmacological Management01:29

Inflammatory Bowel Disease IV: Pharmacological Management

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Upon diagnosis, managing Inflammatory Bowel Disease (IBD) involves addressing several crucial aspects. The primary goals include resting the bowel, correcting malnutrition, and providing symptomatic relief. Resting the bowel may consist of medications to reduce inflammation and promote healing. Correcting malnutrition is essential, often requiring dietary adjustments and nutritional supplements. Symptomatic relief aims to ease pain, diarrhea, and other discomforts in IBD.
Pharmacologic...
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Inflammatory Bowel Disease II: Crohn's Disease01:30

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Introduction
Inflammatory bowel disease, commonly known as IBD, refers to a collection of disorders that lead to persistent inflammation of the gastrointestinal tract. The two types of IBD are ulcerative colitis, which impacts the colon, and Crohn's disease, which can involve any part of the gastrointestinal segment.
Crohn's disease
Crohn's disease is a chronic, systemic inflammatory bowel disease (IBD) that predominantly affects the gastrointestinal tract. It is marked by...
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Inflammatory Bowel Disease III: Diagnostic Studies and Management I-Nutritional Therapy01:30

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Various diagnostic tests are employed in the diagnostic process for Inflammatory Bowel Disease (IBD), particularly to differentiate between Crohn's disease and ulcerative colitis.
Diagnostic studies
A colonoscopy is the definitive screening test, distinguishing ulcerative colitis from other colon diseases with similar symptoms. During a colonoscopy test, inflamed mucosa with exudate ulcerations can be observed, and biopsies are taken to determine the histologic characteristics of the...
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Drugs for Treatment of Crohn's Disease in IBD Using Immunomodulatory Agents01:29

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Crohn's disease is an inflammatory bowel disorder marked by chronic inflammation of the GI tract. Various treatment strategies for Crohn's disease are employed, such as immunomodulatory agents, glucocorticoids, and biologics or anti-TNF therapy. Azathioprine (Imuran), a commonly used immunomodulatory drug for Crohn's disease, is converted in the body to mercaptopurine, which inhibits purine biosynthesis and cell proliferation. Both are utilized in severe cases of Inflammatory Bowel...
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Inflammatory Bowel Disease V: Surgical Management01:21

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Surgical interventions for inflammatory bowel disease (IBD), which includes ulcerative colitis and Crohn's disease, are essential in managing symptoms and addressing complications. The selection of surgical procedures is contingent upon the specific conditions and complications that stem from these illnesses.
Here are some common surgical interventions for IBD:
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Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

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Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
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Real-World Effectiveness, Safety and Quality of Life With Ustekinumab for the Treatment of Crohn's Disease: Results of the UK Ustekinumab Real World Evidence Study (UndieS) Study Group.

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CORE-IBD: A Multidisciplinary International Consensus Initiative to Develop a Core Outcome Set for Randomized

, Christopher Ma1, Jurij Hanzel2

  • 1Division of Gastroenterology and Hepatology, Departments of Medicine and Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada; Alimentiv Inc, London, Ontario, Canada.

Gastroenterology
|July 5, 2022
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Summary

A new core outcome set for Crohn's disease and ulcerative colitis trials was developed. This harmonizes endpoints for better drug development in inflammatory bowel disease.

Keywords:
Crohn’s DiseaseEnd PointOutcomesUlcerative Colitis

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Area of Science:

  • Gastroenterology
  • Clinical Trials
  • Drug Development

Background:

  • Evolving end points for Crohn's disease (CD) and ulcerative colitis (UC) efficacy and safety assessments.
  • Heterogeneity in current outcome measures necessitates harmonized end points for inflammatory bowel disease (IBD) drug development.
  • Need for a standardized core outcome set in randomized controlled trials (RCTs) for IBD.

Purpose of the Study:

  • To establish a consensus-based core outcome set for CD and UC clinical trials.
  • To harmonize outcome measures for consistent drug development in IBD.
  • To create a standardized framework for evaluating therapies in CD and UC.

Main Methods:

  • Systematic literature reviews and patient engagement surveys/interviews to identify candidate outcomes.
  • Iterative Delphi process with international stakeholders (gastroenterologists, surgeons, methodologists, clinical trialists) for consensus building.
  • Consensus meetings to ratify outcome domains and core measures using a 9-point Likert scale.

Main Results:

  • 235 patients and 53 experts participated.
  • Core domains identified: patient-reported outcomes, quality of life, endoscopy, biomarkers, safety (histopathology for UC).
  • Specific end points for CD (e.g., 2-item PRO, CDAI, SES-CD, CRP, Fecal Calprotectin) and UC (e.g., Mayo Score, fecal urgency, RHI/Geboes, Fecal Calprotectin) were agreed upon.

Conclusions:

  • The first core outcome set for CD and UC RCTs has been established through multidisciplinary collaboration.
  • This core outcome set provides a harmonized approach to evaluating IBD therapies.
  • Application of this set will improve consistency and comparability in IBD clinical trials.