Differentiating intestinal tuberculosis from Crohn's disease
Validation of Scoring Systems for Differentiating Intestinal Tuberculosis from Crohn's Disease Utilizing Clinical, Endoscopic, and Interferon-gamma Releasing Assay in Asian Population
This study is trying to find better ways to tell apart intestinal tuberculosis from Crohn's disease in adults with certain types of bowel ulcers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 84 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mahidol University Academic / other |
| Locations | 2 sites (Bangkok Noi, Bangkok and 1 other locations) |
| Trial ID | NCT06629194 on ClinicalTrials.gov |
What this trial studies
This study aims to improve the diagnostic accuracy for distinguishing between intestinal tuberculosis (ITB) and Crohn's disease (CD) in patients undergoing colonoscopy. It evaluates various clinical, endoscopic, pathological, radiological, and serological findings to validate scoring systems that can help differentiate these two conditions. The study involves patients aged 18 and older who have ileal or colonic ulcers and have undergone specific mycobacterial tests. By identifying reliable diagnostic parameters, the study seeks to reduce misdiagnosis and improve treatment outcomes for affected patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with either intestinal tuberculosis or Crohn's disease and are undergoing colonoscopy.
Not a fit: Patients who do not have ileal or colonic ulcers or who have already been definitively diagnosed with either condition may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses and appropriate treatments for patients suffering from intestinal tuberculosis and Crohn's disease.
How similar studies have performed: Previous studies have shown promising results in developing models to differentiate between these conditions, but this specific validation approach is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bangkok Noi, Bangkok and 1 other locations
- Assoc. Prof. Julajak Limsrivilai, MD — Bangkok Noi, Bangkok, Thailand (Recruiting)
- Gastroenterology division, Faculty of Medicine, Siriraj Hospital, Mahidol University — Bangkok, Thailand (Not_yet_recruiting)
Study contacts
- Principal investigator: Julajak Limsrivilai — Division of Gastroenterology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
- Study coordinator: Julajak Limsrivilai
- Email: alimsrivilai@gmail.com
- Phone: +66814968895
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.