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Validation of Scoring Systems for Differentiating Intestinal Tuberculosis from Crohn's Disease

Recruitingn/aAges 18 Years - anyAllMahidol University
NCT06629194 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Differentiating CD from intestinal tuberculosis (ITB) is difficult due to the low sensitivities of currently available diagnostic tests. The Asia-Pacific guideline recommends anti-tuberculous therapy (ATT) for 8-12 weeks in patients with diagnostic uncertainty due to the risk of disseminated tuberculosis if patients with ITB are misdiagnosed with CD, and are prescribed immunosuppressive therapy. However, treatment with ATT has many side effects and may delay treatment in patients with CD, and this may cause severe relapse and developing complications. Many studies found that some clinical, endoscopy, pathology, radiology, and serology findings can help to improve diagnostic accuracy in these patients. However, no single diagnostic parameter can distinguish between CD and ITB. As a result, many models were developed that include various factors and modalities, and many of those models hav

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Patients ages 18 years or older 2. Undergoing colonoscopy and found ileal or colonic ulcers 3. Have ileal and/or colonic tissue sent for mycobacterial tests, including stain for AFB, PCR, and culture 4. Diagnosed with either intestinal tuberculosis or Crohn's disease a. Criteria of intestinal tuberculosis diagnosis includes any of following: i. Presence of caseating granuloma on pathological examination of specimens ii. Presence of acid-fast bacilli on pathological examination of specimens iii. PCR positive for Mycobacterium tuberculosis iv. Tissue culture growing organisms consistent with Mycobacterium tuberculosis v. Negative results in i to iv but response to empirical treatment with antituberculous therapy All are required to have clinical and endoscopic response to antituberculous therapy (ATT) treatment b. Diagnosis of Crohn's disease is based on clinical, endoscopic, pathological, and/or radiological findings which is confirmed by clinical \& endoscopic response to Crohn's disease treatment Exclusion Criteria: 1\. Patients with ileal/colonic ulcers caused by other diseases
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What it tests

  • interferon gamma releasing assay (IGRA)
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Where

2 sites
Assoc. Prof. Julajak Limsrivilai, MD
Bangkok Noi, Thailand
Gastroenterology division, Faculty of Medicine, Siriraj Hospital, Mahidol University
Bangkok, Thailand
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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