Crohn'sRecruiting
Validation of Scoring Systems for Differentiating Intestinal Tuberculosis from Crohn's Disease
Observational · No treatment assigned · 2 sites · Mahidol University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Crohn Disease, Intestinal Tuberculosis and Differential Diagnosis. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- Patients ages 18 years or older
- Undergoing colonoscopy and found ileal or colonic ulcers
- Have ileal and/or colonic tissue sent for mycobacterial tests, including stain for AFB, PCR, and culture
Plus 1 more requirement(s). There are also 1 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 84 participants are expected to take part.
- Start date: 2024-06-09.
- Main results expected around 2025-12-31 (estimate from the record).
- 2 study sites listed (1 marked recruiting) in Thailand.
Main thing being measured
- Accuracy of the ITBvsCD model (with 4 weeks of colonoscopy)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Crohn Disease; Intestinal Tuberculosis; Differential Diagnosis |
| Lead sponsor | Mahidol University |
| Collaborators | Korean Association for the Study of Intestinal Diseases |
| Enrollment | 84 (estimated) |
| Start date | 2024-06-09 |
| Primary completion (est.) | 2025-12-31 |
| First posted | 2024-10-08 |
| Last updated | 2024-10-08 |
| Official title | Validation of Scoring Systems for Differentiating Intestinal Tuberculosis from Crohn's Disease Utilizing Clinical, Endoscopic, and Interferon-gamma Releasing Assay in Asian Population |
| ClinicalTrials.gov ID | NCT06629194 |
Interventions
- interferon gamma releasing assay (IGRA) (Diagnostic Test)
All patients who suspected CD or TB will be tested for interferon-gamma releasing assay. An interferon-gamma release assay is a blood test that measures the body\'s immune response to Mycobacterium tuberculosis, the bacteria that causes tuberculosis.
Full eligibility criteria (from the record)
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
Locations (2)
| Site | City | Country | Site status |
|---|---|---|---|
| Gastroenterology division, Faculty of Medicine, Siriraj Hospital, Mahidol University | Bangkok | Thailand | Not yet recruiting |
| Assoc. Prof. Julajak Limsrivilai, MD | Bangkok Noi, Bangkok | Thailand | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.