NCT06629194 Validation of Scoring Systems for Differentiating Intestinal Tuberculosis from Crohn's Disease
| NCT ID | NCT06629194 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mahidol University |
| Condition | Crohn Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 84 participants |
| Start Date | 2024-06-09 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 84 participants in total. It began in 2024-06-09 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 have been reported to have high performance. However, the number of studies performed to validate those models externally was limited. Correspondingly, this study is designed to prospectively validate models that integrate more advanced parameters (e.g., IGRA, CT enterography findings) with clinical, endoscopic, or pathological findings. However, it aims mainly to evaluate the model integrating clinical, endoscopic, and serological variables since CT enterography and pathological interpretation require experienced radiologists and pathologists but they are not available in many centers.
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
Contact & Investigator
Julajak Limsrivilai
PRINCIPAL INVESTIGATOR
Division of Gastroenterology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
Frequently Asked Questions
Who can join the NCT06629194 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Crohn Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06629194 currently recruiting?
Yes, NCT06629194 is actively recruiting participants. Contact the research team at alimsrivilai@gmail.com for enrollment information.
Where is the NCT06629194 trial being conducted?
This trial is being conducted at Bangkok Noi, Thailand, Bangkok, Thailand.
Who is sponsoring the NCT06629194 clinical trial?
NCT06629194 is sponsored by Mahidol University. The principal investigator is Julajak Limsrivilai at Division of Gastroenterology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand. The trial plans to enroll 84 participants.