Actively Recruiting
Validation of Scoring Systems for Differentiating Intestinal Tuberculosis from Crohn's Disease Using Clinical, Endoscopic, and Interferon-gamma Releasing Assay in Asian Population
Led by Mahidol University · Updated on 2024-10-08
84
Participants Needed
2
Research Sites
8 weeks
Total Duration
On this page
Sponsors
M
Mahidol University
Lead Sponsor
K
Korean Association for the Study of Intestinal Diseases
Collaborating Sponsor
AI-Summary
What this Trial Is About
Differentiating Crohn's disease (CD) from intestinal tuberculosis (ITB) is challenging because current diagnostic tests have low sensitivity. This research aims to validate scoring models that combine clinical, endoscopic, and serological data, including interferon gamma-releasing assay (IGRA) results, to improve diagnosis accuracy. The study focuses on models suitable for resource-limited settings, as advanced imaging and pathology may not be widely available. Accurate distinction is important to avoid incorrect treatment, which can lead to complications or severe relapse. Participants diagnosed with either Crohn's disease or intestinal tuberculosis will be included. Diagnosis of CD is based on clinical, endoscopic, pathological, or radiological findings confirmed by treatment response. ITB diagnosis requires specific pathological or microbiological evidence or a positive response to anti-tuberculous therapy (ATT). All patients suspected of CD or ITB will undergo IGRA blood testing. The study evaluates the accuracy of diagnostic models, including those integrating clinical, endoscopic, and serological findings. During the study, patients will undergo colonoscopy and have tissue samples tested for mycobacterial infections using stains, PCR, and cultures. Researchers will assess the accuracy of scoring models using colonoscopy results after four weeks. Participants will be monitored for clinical and endoscopic responses to their respective treatments—either Crohn's disease therapies or ATT. This observational study will help validate diagnostic tools to better distinguish between CD and ITB and improve patient care.
CONDITIONS
Brief Title
Validation of Scoring Systems for Differentiating Intestinal Tuberculosis from Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients ages 18 years or older
- Undergoing colonoscopy with ileal or colonic ulcers found
- Have ileal and/or colonic tissue sent for mycobacterial tests including stain for AFB, PCR, and culture
- Diagnosed with either intestinal tuberculosis or Crohn's disease
- For intestinal tuberculosis diagnosis, must have one of the following: caseating granuloma on pathology, acid-fast bacilli on pathology, PCR positive for Mycobacterium tuberculosis, tissue culture growing Mycobacterium tuberculosis, or negative results but clinical and endoscopic response to anti-tuberculous therapy
- For Crohn's disease diagnosis, based on clinical, endoscopic, pathological, and/or radiological findings confirmed by response to Crohn's disease treatment
You will not qualify if you...
- Patients with ileal or colonic ulcers caused by diseases other than Crohn's disease or intestinal tuberculosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 weeks
Participants undergo diagnostic tests including colonoscopy with tissue sampling and interferon gamma releasing assay (IGRA) to differentiate between Crohn's disease and intestinal tuberculosis.
1 to 2 visits depending on diagnostic procedures
Duration - Variable duration following diagnosis
Participants diagnosed with either Crohn's disease or intestinal tuberculosis are observed to confirm diagnosis based on clinical and endoscopic response to their respective treatments.
Visits scheduled according to clinical follow-up needs
Trial Site Locations
Total: 2 locations
1
Assoc. Prof. Julajak Limsrivilai, MD
Bangkok Noi, Bangkok, Thailand, 10700
Actively Recruiting
2
Gastroenterology division, Faculty of Medicine, Siriraj Hospital, Mahidol University
Bangkok, Thailand, 10700
Not Yet Recruiting
Research Team
J
Julajak Limsrivilai
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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