Health Condition 1: K633- Ulcer of intestine
Conditions
Interventions
Intervention1: Corticosteroids (Prednisone): Prednisone 1mg/kg upto 40 mg/day for 2 weeks followed by tapering of the drug dose by 5 mg every 2 weeks
Control Intervention1: Antitubercular Therapy (ATT
Sponsors
All India Institute of Medical Sciences, New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1. Symptoms suggest Crohn?s disease or intestinal TB, such as stomach pain, diarrhea, bleeding, fever, or weight loss 2. Endoscopic evidence of ulceroconstrictive lesions in the bowel (ileo-colonoscopy with biopsy, capsule endoscopy, balloon enteroscopy). 3. Radiological evidence of bowel inflammation or stricture (Ultrasound, CT enterography, MRI enterography). 4. Patients where Crohn?s disease or intestinal TB cannot be clearly diagnosed, even after biopsy, and TB-specific tests like Gene Xpert are negative or inconclusive 5. Clinical symptoms requiring immediate therapeutic intervention (moderate-to-severe symptoms, weight loss, fever, significant abdominal pain). 6. Agree to give informed consent
Exclusion criteria
Exclusion criteria: Definitive diagnosis of intestinal tuberculosis (e.g., positive AFB culture/Tissue Gene Xpert from biopsy, characteristic caseating and confluent granulomas on histopathology, necrotic lymph nodes on radiological examination, clear response to diagnostic ATT in a non-trial setting). Presence of active tuberculosis elsewhere which would mandate immediate ATT Perianal complex fistulising disease Duration of symptoms for more than 3 years Pregnant or breastfeeding women Known contraindications to systemic corticosteroids or any first-line anti-tubercular drug Immuno-compromised status (HIV/AIDS, organ transplant recipients on immuno-suppressants) Prior treatment for the current episode of bowel disease (recent i.e less than 4 weeks steroids, ATT, advanced therapy for CD). Patients requiring emergency surgery Inability to understand or comply with the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients in each arm definitively diagnosed with CD or ITB based on follow-up investigations (response to therapy and colonoscopic findings)Timepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical Outcomes Time to clinical remission in each arm. 2. Endoscopic Outcomes Mucosal healing as assessed by resolution of presenting lesions in the ATT arm and change in endoscopic scores (Simple Endoscopic Score for Crohns Disease) in the corticosteroid arm. 3. Radiological Outcomes Improvement in bowel wall thickness, inflammation, or stricture length or severity on CT or MRI enterography and IBUS or deterioration in the form of development of necrotic lymph nodes and active pulmonary TB, assessed by radiology 4. The incidence of drug-related adverse events in each arm. 5. Surgical Outcomes Rates of elective vs. emergency surgery and post-operative complications in each arm. 6. Biomarkers: changes in inflammatory markers (CRP, ESR, fecal calprotectin) in each armTimepoint: 4/8 and 24 weeks | — |
Countries
India
Contacts
Public ContactMridul Mahajan
All India Institute of Medical Sciences, New Delhi
Outcome results
None listed