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Search / Trial NCT06629194

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

Launched by MAHIDOL UNIVERSITY · Oct 4, 2024

Trial Information

Current as of July 09, 2025

Recruiting

Keywords

Intestinal Tuberculosis Crohn Disease

ClinConnect Summary

This clinical trial is looking to improve the way doctors can tell the difference between two similar conditions: Crohn's disease and intestinal tuberculosis. These conditions can cause similar symptoms, making it hard to diagnose correctly. If someone is misdiagnosed with Crohn's disease when they actually have intestinal tuberculosis, they might receive the wrong treatment, which can lead to serious health issues. The trial aims to test new models that combine different tests and information from patients to help make a more accurate diagnosis.

To join this study, participants must be at least 18 years old and have ulcers in their intestines that have been examined through a procedure called colonoscopy. They also need to have tissue samples tested for tuberculosis. The researchers will be looking for people who have already started treatment for either condition and responded well. If you decide to participate, you will help improve the understanding of these diseases and potentially help others in the future.

Gender

ALL

Eligibility criteria

  • 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

About Mahidol University

Mahidol University, a premier institution in Thailand, is dedicated to advancing healthcare through innovative research and education. As a leading sponsor of clinical trials, the university leverages its extensive expertise in medical and health sciences to facilitate rigorous scientific investigations aimed at improving patient care and public health outcomes. With a commitment to ethical practices and collaboration, Mahidol University fosters multidisciplinary approaches, engaging a diverse array of researchers and healthcare professionals to drive meaningful advancements in clinical research.

Locations

Bangkok, , Thailand

Bangkok Noi, Bangkok, Thailand

Patients applied

0 patients applied

Trial Officials

Julajak Limsrivilai

Principal Investigator

Division of Gastroenterology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported